New 6-ply design, composed of 45gsm Spunbond PP Non-Woven + 25gsm Spunbond PP Non-Woven + 25gsm BFE99 Meltblown Non-Woven + 25gsm Hot Air-Flow Cotton Non-Woven + 25gsm BFE99 Meltblown Non-Woven + … The KN95 is the Chinese equivalent to the US N95. They all WRAP COMPLETELY around the head! Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.”. According to the standard GB2626-2006, the material in the KN95 face mask is designed for filtration efficiency of at least 95% of particulate matter >0.3 microns. HOWEVER, I am finding that some of the respirators being offered to us are counterfeit N95 respirators. The registration certificate states the following: “Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Neither of us has had any luck in getting an official reply from Dasheng. Dasheng was making the old KN95 style earloop design DTC3X with this new box up until April 2020. But, I have attached an image above to show everyone that there are companies making KN95 with headwraps. KN95 and N95 masks have the same level of protection, they only follow the testing standards of different countries. My current conclusion is that Dasheng makes both the official NIOSH respirator and the KN95 respirators that have been mislabeled on the box as NIOSH. 1. There are REAL Chinese NIOSH respirators being copied into counterfeits. They can probably be used in non-high risk settings. We want the quality respirators with the tightest seal and not any respirator that will let the thief into the bank vault. PLEASE NOTE: This article is being constantly updated as I receive new, accurate information about this on-going problem. These numbers are reinforcing concerns of many health care officials that infection rates … If a KN95 is manufactured under Chinese GB2626–2006, then it can not automatically advertise that it is an FFP2 or NIOSH, as it is not always manufactured under other performance standards. So, if your Chinese KN95 respirator has an FDA logo on the box, then you are probably importing a non-authorized KN95 respirator. Difference between FDA registration and FDA approval.3. According to the standard GB2626-2006, the material in the KN95 face mask is designed for filtration efficiency of at least 95% of particulate matter >0.3 microns. Imagine that your face is a bank vault, the mask is a bank vault door and the virus is a thief. It should be noted that Dasheng does make official NIOSH respirators, but the real NIOSH Dasheng respirator’s elastic wraps completely around the head. I was told by a few Chinese suppliers that the “counterfeit NIOSH” or earloop KN95 seen in the header photo is also made by Dasheng. Many companies will try to mislead you to believe that their KN-95 is FDA-approved by submitting an FDA registration certificate as proof. About this product. Earloops For example, many suppliers have told me that China has forbidden the export of Dasheng respirators on the counterfeit N95 list. Your FDA certificate is likely an FDA registration certificate and not an FDA-approval. The transition period started on 31 December 2019 and was scheduled to end on 1 July 2020. If you want to help provide masks and gowns to our medical providers in NYC, then please donate to Bstrong initiative at Global Empowerment Mission. It should be noted that many of the earloop KN95s are more comfortable to wear than tight headwrap N95 that causes facial impression marks with prolonged use. So, if you already imported fake KN95 or counterfeit N95, then tell the hospitals and providers about what they actually are. The majority of the KN95 have earloops which creates a looser seal. While the quality of the respirator material may provide 95% filtration, the seal is inadequate to pass the fit testing on most medical providers. 9. This standard applies to non-powered air-purifying respirator which can help provide respiratory protection against particles. N95 KN95 P2 Mask GB2626 2006 complied face mask These are high quality KN95 GB2626-2006 complied face masks with below certificates and test report , manufactured by NEP CTT. 3. Thankfully, the Ministry of Commerce in China has recently started to crack down on its own export along with the FDA guidelines. Difference between FDA registration and FDA approval. Break down of Certified mask components FDA. I appreciate everyone’s heart and effort during this crisis by providing us with their export distributors in China. The door should be as thick as possible to reduce the possibility of a thief going through the door (N95 means 95% filtration). Over 100 KN95s were removed from the EUA by the FDA in one day because most KN95s were low-quality. As of May 2020, Dasheng no longer makes earloop style DTC3X. DISCLAIMER: The topics and articles published on this website including text, graphics, videos info graph and other material are for informational purposes only and should not be substituted for professional medical advice. However, not ALL KN95 was authorized for use. We want the quality respirators with the tightest seal and not any respirator that will let the thief into the bank vault. KN95 is one of the levels specified in the Chinese Standard GB2626-2006 . $2.95/Each Sold in increments of 10Minimum order: 10 The Chinese are notorious for exporting counterfeit goods. The flip side of this is the FDA has given authorization for the use of KN95 under the EUA. 1. Also, I believe that these KN95 respirators might be safe to be used in lower risk settings (Recently, the Chinese government told European countries to “double check instructions.” On one of the boxes shown above, it states “Civil Grade.”) However, we, as suppliers and distributors, still have an obligation to be transparent about our products. The HHS issued a declaration to provide liability immunity for claims against the distribution of PPE. This item 10-Pack KN95 (EUA Listed Appendix A Authorized Respirator), Protective Face Mask, Disposable Particulate Respirator, GB2626-2006 (10-Count) Powecom KN95 Face Mask on FDA List, 10 Pack Disposable Masks, Protection Against PM2.5 from Fire Smoke, Dust for Adults, Men, Women, Essential Workers - 10 Pcs Europe has also set up a similar website. FDA registration … Over 100 KN95s were removed from the EUA by the FDA in one day because most KN95s were low-quality. Spotting a Fake –Understanding FFP Markings Chinese Standard GB2626-2006 requires a KN95 to have the following markings: Manufacturer name or logo 3M Manufacturer model number 9505Z Filtering facepiece class KN95 Chinese Standard GB2626-2006 For example: 07/05/2020 KN95 6 This standard for the KN95 is called GB2626-2019 and was to go alongside the GB2626-2006. People have different ear sizes and distances from the face to the ear. They all LOOP around the ears! It should be noted that Dasheng does make official NIOSH respirators, but the real NIOSH Dasheng respirator’s elastic wraps completely around the head. SOME of these “ear loop” respirators are NOT tight enough. KN95: GB2626-2006 or. This registration certificate is given to a company that paid the FDA fee to get registered. It is a class 2 device that only requires FDA clearance. How can you tell the difference between earloop Dasheng DTC3X made in April versus headwrap Dasheng DTC3X made in May? The difference in the elastic is in the analogy about the bank vault door and the door frame seal. The launch date for this is July 1st, 2020. KN95 Part 2: How to identify suspicious, fake or misleading marks & certificates with your KN95 respirator mask.Alternative Medicine Treatment for COVID-19? But, if you withhold this knowledge, then you are probably engaging in “willful misconduct.”, Conclusion: How to spot a counterfeit or low-grade N95/NIOSH/KN95 respirator mask.FDA logo on the boxFDA registration certificate as proof of “FDA approval”LOOSE earloops (Not all earloops are poor quality)Loosely packed masks without any packaging or labeling. Individually packed. A trusted supplier has told me that Dasheng has changed the packaging. [Updated: 5/14/20]. Thankfully, the Ministry of Commerce in China has recently started to crack down on its own export along with the FDA guidelines. HOWEVER, I am finding that over 90% of the products being offered to us are NOT real N95 equivalent respirators. I was skeptical that DTC3X have different styles, until I saw the Dasheng DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 appear on the list of FDA Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China. KN95 (China GB2626–2006) Many of us using N95 respirators are face to face with coughing or vomiting patients. Spot FAKE KN95/NIOSH/N95 knockoffs.5. FDA does NOT allow a vendor to put the FDA logo on the box of a respirator. We have already imported several of these low-quality respirators and have found that the fit is poor and the elastic is too loose to pass a hospital fit testing. GB2626-2006 Chinese Standard Kn95 Face Mask, Find details about China Kn95 Face Mask, Anti Dust from GB2626-2006 Chinese Standard Kn95 Face Mask - Sterivic Medical Co., Ltd. Also, I am starting a solution where we will create the first online, open marketplace for qualified suppliers and end-users of authentic PPE: How to Spot Fake, Counterfeit Watson 853 White Pill [Norco], How To Spot Fake Green Xanax Bars [S 90 3 Fake], Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China, FDA removed 65 manufacturers from this appendix A, How to Spot T 259 Yellow Pill Fake Vs Real, How To Spot Dr James Glutathione Fake And Original, The negative effects of improperly managing your diabetic issues are incredibly severe. 4. As of May 2020, Dasheng no longer makes earloop style DTC3X. Most suppliers don’t know this, but 3M respirators that are FDA-cleared have different sizes. | The Misappropriation of Women’s Bodies during the Coronavirus Epidemic. In this upgrade there are some additional standards for the KN95 to meet, but the GB2626-2006 is still a valid KN95 standard and can be used safely. I understand the dire need as some of us are using garbage bags as additional PPE. Also, we have started two websites where we have vetted authentic 3M and Honeywell respirators.KN95RespiratorMasksForSale.com: Group Buy deal for respirators from factories in China (GROUPON for PPE).PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPEPPECertification.com: PPE background check and fraud alerts. So, if you already imported fake KN95 or NIOSH, then tell the hospitals and providers about what they actually are. The result of the fit testing for these higher-quality head wrap KN95 is better than the lower-quality earloop KN95. Here are several clever id, Cardarine (GW501516) Dosage: How to Use Cardarine, If you or somebody you know is experiencing major depression, it is crucial that they are aware the particulars of the situation to allow them to help make on their own feel much better. Counterfeit Chinese NIOSH respiratorsThe Chinese are notorious for exporting counterfeit goods. FFP1 respirators filter up to 80%, therefore they are NOT N95 equivalent. The difference in the elastic is in the analogy about the bank vault door and the door frame seal. Shall we still buy KN95 respirators? Two Chinese certifications can currently be used to certify KN95-FFRs. I truly believe and hope that many of us are stepping up to the call and providing our front line medical staff with proper PPE. FDA has a TWO step process where ANY company can REGISTER their product with the FDA before getting clearance or approval. It is not. FFP2 (Europe EN 149–2001) The closest European equivalent of N95 is FFP2 & P2 grade respirators, which are rated at 94%. Most KN95 ear loop respirators might be adequate for civil use, but the seal may not be good enough for medical use. This registration certificate is given to a company that paid the FDA fee to get registered. P.P.S. China also needs us. If a KN95 is manufactured under Chinese GB2626–2006, then it can not automatically advertise that it is an FFP2 or NIOSH, as it is not always manufactured under other performance standards.N95 (United States NIOSH-42CFR84)FFP2 (Europe EN 149–2001)KN95 (China GB2626–2006)P2 (Australia/New Zealand AS/NZA 1716:2012)Korea 1st class (Korea KMOEL — 2017–64)DS2 (Japan JMHLW-Notification 214, 2018). My current conclusion is that Dasheng makes both the official NIOSH respirator and the KN95 respirators that have been mislabeled on the box as NIOSH. Your importing of fake or lower quality respirators may cause one of my colleagues to die from the lack of proper protection. Do you notice the elastic bands? Since publication, I have been accused of ignorance, because the “KN95 experts” tell me that “ALL KN95 HAVE EAR LOOPS.” I am no expert on this, I agree. However, not ALL KN95 was authorized for use. The CDC later wrote this smoking gun about this product which states that it is an earloop respirator from Dasheng. But, I have attached an image above to show everyone that there are companies making higher-quality KN95 with headwraps. Add to Cart Up to quantity 1600 ships same day. I understand the dire need as some of us are using garbage bags as additional PPE. KN95, KN95 Mask, Mask KN95 manufacturer / supplier in China, offering GB2626-2006 Standard KN95 Respirator Disposable Civilian Protective Folding Dust Face Mask, Hi Vis Breathable Reflective Safety Vest with Custom Logo, Wholesale Disposable Dustproof for Adult Medical Surgical CE Ear Loop & Tie on Face Mask … These are examples of the FDA-cleared N95 respirators from 3M. Loosely packed masks without any packaging or labeling. FDA doesn’t approve N95 respirators. N95 (United States NIOSH-42CFR84) FFP2 (Europe EN 149–2001) KN95 (China GB2626–2006) 3. Unfortunately, it is no different when it comes to NIOSH(NIOSH is similar to N95). P.S. The door should be as thick as possible to reduce the possibility of a thief going through the door (N95 means 95% filtration). EU FFP2 (KN95 is the Chinese Standard and how these masks are commonly known) CE Marked / Certified and supplied by Official Approved Manufacturers to GB2626-2006 EN149-2001 5 Ply Woven With Metal Nose adjustment tight fitting to create a … However, there is no independent certification or assurance of their quality and products manufactured to KN95 … Please don’t take this post as an attack on China. This KN95 GB2626-2006 filtering face mask is form fitting to the face and can be adjusted for a more comfortable fit to your face. Lower-quality KN95 have ear loops KN95 masks follow Chinese standards, N95 masks follow US standards, and both of them are not less than 95% in protection against particles of 0.3 microns such as viruses and … Is Dasheng NIOSH a counterfeit N95 or manufacturer error?8. But please understand that while something might be better than nothing, the way we interact with patients while using an N95 respirator is different than a simple surgical mask. Different countries will use different labeling to indicate similar functions. A trusted supplier has told me that Dasheng has changed the packaging. Is Dasheng NIOSH a counterfeit or manufacturer error? USE AS SUITABLE ALTERNATIVE TO NIOSH N95. Your email address will not be published. NPPTL makes no representation as to the authenticity of the samples received and assessed. 4.3 out of 5 stars 2,926 ratings | 3 answered questions Price: $20.00 ($4.00 / Item) FREE Shipping Get free shipping Free 5-8 day shipping within the U.S. when you order $25.00 of eligible items sold or fulfilled by Amazon. A journalist from WSJ who contacted me also came to the same conclusion. Why is that? I have been getting angry responses and LinkedIn messages about this. Here is the list of KN95 that are Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China as per the FDA. It is not. P.P.P.S. Disposable 5 Layers Gb2626-2006 Kn95 Disposable Face Mask , Find Complete Details about Disposable 5 Layers Gb2626-2006 Kn95 Disposable Face Mask,Kn95 Face Mask,Gb2626-2006 Kn95 Face Mask,Kn95 Disposable Face Mask from Respirators & Masks Supplier or Manufacturer-Zhejiang Kaiqi Environmental … Counterfeit Chinese NIOSH respirators Since many of you do not know about the FDA regulations and why medical providers need high-quality N95 respirators, please let me guide you. China KN95 Mask Respirator/ Protective/Dust GB2626-2006 Standard Safety Face Mask, Factory Source, Find details about China KN95 Mask, Face Mask from KN95 Mask Respirator/ Protective/Dust GB2626-2006 Standard Safety Face Mask, Factory Source - Zhejiang Igooddoc Health Tech Co., Ltd. PRICE: R26.00 ZAR / pc CLICK TO DOWNLOAD DOCUMENTATION: KN95 FFP2 CE-Certificate Function – Anti-Dust, Anti-Bacteria, Anti-Virus Brand name – ZH Model number – LT-C1086, LT-C2069 10 pcs Face Masks per box Colour – White Material – Non-Woven Fabric Size – 12.5cm*14.5cm Weight – 1.8g FDA logo on the boxFDA does NOT allow a vendor to put the FDA logo on the box of a respirator. Let me say this again: If the box or the label has an FDA logo, then it is DEFINITELY NOT FDA APPROVED. We have already imported several of these low-quality respirators and have found that the fit is poor and the elastic is too loose to pass a hospital fit testing. DISCLAIMER: This article is being constantly updated as I receive new, accurate information about this on-going problem of counterfeit N95 or fake KN95. KN95, Face Mask, Disposable manufacturer / supplier in China, offering GB2626-2006 Civil Grade Respirator Face Mask Disposable Dust Folding Respirator, Mask N95 PPE Factory Disposable Melt-Blown 5 Ply KN95 Non Medical Use Face Mask, Disposable Mask KN95/FFP2/N95 Prevent Dust Anti Pm2.5 for Civil Use and so on. They can probably be used in non-high risk settings. [Updated 5/14/20] Does your supplier state the masks are ‘FDA Approved’? Free & Fast Shipping From NJ! We have purchased and used good quality KN95s from China that has passed the CDC filtration test. Once again, FDA registration is NOT FDA approval. This KN95 GB2626-2006 filtering face mask is form fitting to the face and can be adjusted for a more comfortable fit to your face. Your FDA certificate is likely an FDA registration certificate and not an FDA-approval. Even Honeywell makes KN95s with headwraps (3M KN95 also with headwraps). Also, different respirators are manufactured for different standards. Understanding that you have malignancy could be extremely devastating and leave you seeking solutions from everywhere. 4 easy ways to help spot a low-quality respirator. I was skeptical that DTC3X has different styles until I saw the Dasheng DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 appear on the list of FDA Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China. FDA registration certificate as proof of “FDA approval” Why high-quality N95 is important. This is the easiest way to help spot a KN95 that is NOT FDA approved. Low vs High-quality N95, NIOSH, KN95Imagine that your face is a bank vault, the mask is a bank vault door and the virus is a thief. Since many of you do not know about the FDA regulations and why medical providers need high-quality N95 respirators, please let me guide you. Why the FDA logo on the box means NOT FDA approved. FDA doesn’t approve N95 respirators. Know your N95 equivalentWe recently received a shipment of official European 3M FFP1 respirators from a vendor who misleadingly said that they were N95. Zinc and Green tea.Why Rapid COVID-19 Tests are “CRAPPY”.How to verify a legitimate KN95 supplier? Save my name, email, and website in this browser for the next time I comment. Kn95 Mask, Kn95 Face Mask, Mask manufacturer / supplier in China, offering GB2626-2006 KN95 Safety Disposable Protective Face Mask, 1ml Sterile Hypodermic Syringe Luer Slip with CE & ISO, 1ml Sterile Hypodermic Syringe for Single Use with CE & ISO and so on. On behalf of all the medical providers worldwide, we thank you, the ethical manufactures and suppliers, for your heart and effort. We recently received a shipment of official European 3M FFP1 respirators from a vendor who misleadingly said that they were N95. Furthermore, all hospital employees undergo fit testing to ensure a tight seal. The CDC has also set up a webpage with the list of its NIOSH-approved respirators. We are all in this together. **Stock Images** Stock photos have been used in this listing. Also, different respirators are manufactured for different standards. On behalf of all the medical providers worldwide, we thank you, the ethical manufactures and suppliers, for your heart and effort. Since March, I’ve been working with Bstrong and GEM to help authenticate the quality of the KN95 (N95 equivalent from China) respirators. 3D Mask, Kn95, Ear Loop manufacturer / supplier in China, offering 3D Mask Kn95 Face Mask Executive Standard GB2626-2006, Custom Medical Surgical Hospital Disposable 3ply Face Maskget Latest Price, Protective Surgical Medical Face Mask, Doctor′s Mask, Surgical Mask, Bfe95mask, Bfe99mask, 3-Ply Face Mask … However, the SEAL of the door on the door frame is equally important. Your importing of fake or lower quality respirators may cause one of my colleagues to die from the lack of proper protection. You might kill a medical provider by giving them a bad respirator.9. This is why many health care workers have a mask-shaped bruise or line on their faces. 6. He says that you can’t tell by the box, but you have to open it up and look at the respirator. 7. However, it does not cover you from claims involving “willful misconduct.” Knowingly distributing fraudulent KN95 probably puts you in the “willful misconduct” category. KN95 Face Mask, Mask, Face Mask manufacturer / supplier in China, offering Wholesale KN95 Mask, GB2626-2006, En149-2001 FFP2 Protective Respirator Anti-Virus Dust Facial Mask Distributor Disposable Kn 95 KN95 Face Mask, Disposable Protective Dust Mask Mascarillas KN95 Facemask KN95 Mascarilla, Factory Disposable KN95 … 4. Also, different respirators are manufactured for different standards. N95 is one of the levels specified in the US Standard 42 CFR 84. If your respirator is on this list, then it’s fake and you are a participant in distributing counterfeit products. You possibly will not notice a 6-pack down the road, but beginning nowadays is an essential thing to do when you wish to develop muscle tissue. Here are the low-quality KN95 respirators. Why the FDA logo on the box means NOT FDA approved.4. Outline:1. Therefore, you have been warned.