NOTES
- Note 1:
- This respirator is to be used as a Crisis Capacity Strategy in the CDC prioritization table for use “when N95 supplies are running low” according to the CDC's strategies for optimizing respirator supply
- This KN95 meets a Chinese government standard similar to NIOSH-approved respirators for an equivalent filtration efficiency performance comparable to N95. This respirator has obtained both a marketing authorization under the NMPA registration certification for China and CE mark authorized by a competent notified body for respiratory protective equipment within the scope of Regulation (EU) 2016/425 for Europe.
- This respirator should only be used in crisis situations when no other NIOSH-approved N95 respirator (or a listed device from one of the other countries identified within the FDA EUA) is available.
- This respirator should not be used during aerosol-generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device, and a fit test is performed prior to use.
- Note 2:
-
2a: This respirator is meeting the Chinese Standard GB2626-2006 (KN95), as a part of the “Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators”. (Source: CDC)
- 2b: In accordance with the EUA guidelines, samples of these respirators have also been tested by the CDC’s National Personal Protective Technology Laboratory (NPPTL) for particulate filter efficiency using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. The Filter Penetration Performance has been tested by the NPPTL, a division operating within NIOSH and the CDC (US): View report.
- Note 3:
- While most NIOSH-approved N95s typically have head bands, it is common for respirators in Asia to have ear loops and NIOSH states that “limited assessment of ear loop designs indicate difficulty achieving a proper fit. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved.” Source: CDC.
-
This design tends to fit people with facial features common in China and other countries in Asia and may not be able to achieve a satisfactory fit for all customers users. To provide the expected level of protection, this respirator must be fit tested as part of an overall respiratory protection program in accordance with requirements under OSHA Respiratory Protection standard (29 CFR 1910.134) to ensure that it seals to the wearer’s face, without allowing air leaks to pass through gaps between the respirator and the wearer’s skin. In addition, individuals should read and follow all user instructions, including conducting a user seal check every time they put on a respirator. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator.
-
Note 4: This respirator is not suitable for use in a sterile field or in environments with exposure to high velocity splashes, sprays, or splatters of blood or body fluids, such as in operative or procedural settings. The CDC recommends the use of a Surgical N95 in these settings and a level 3 fluid resistance is required for FDA approval of a surgical N95 respirator. If using in a surgical environment due to a lack of alternatives, it is recommended that you use a face shield approved for medical use with this respirator.
- Note 5: Tested against Chinese standards by laboratories that are ISO/IEC 17025 accredited, by a test lab accredited to act as a notified body for Regulation (EU) 2016/425 Personal protective equipment The European Union Commission website provides a link to the list of Notified Bodies for Personal Protective Equipment in Europe – bodies notified under Regulation (EU) 2016/425 on personal protective equipment. Our on-the-ground team conducts engineering, evaluation, development, production, quality control and quality assurance. We have also validated this product for regulatory compliance, working with a team of regulatory consultants and lawyers with decades of experience conducting medical device reviews with the FDA.
- Not made with latex rubber
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- Note 1:
- This respirator is to be used as a Crisis Capacity Strategy in the CDC prioritization table for use “when N95 supplies are running low” according to the CDC's strategies for optimizing respirator supply
- This KN95 meets a Chinese government standard similar to NIOSH-approved respirators for an equivalent filtration efficiency performance comparable to N95. This respirator has obtained both a marketing authorization under the NMPA registration certification for China and CE mark authorized by a competent notified body for respiratory protective equipment within the scope of Regulation (EU) 2016/425 for Europe.
- This respirator should only be used in crisis situations when no other NIOSH-approved N95 respirator (or a listed device from one of the other countries identified within the FDA EUA) is available.
- This respirator should not be used during aerosol-generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device, and a fit test is performed prior to use.
- Note 2:
-
2a: This respirator is meeting the Chinese Standard GB2626-2006 (KN95), as a part of the “Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators”. (Source: CDC)
- 2b: In accordance with the EUA guidelines, samples of these respirators have also been tested by the CDC’s National Personal Protective Technology Laboratory (NPPTL) for particulate filter efficiency using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. The Filter Penetration Performance has been tested by the NPPTL, a division operating within NIOSH and the CDC (US): View report.
- Note 3:
- While most NIOSH-approved N95s typically have head bands, it is common for respirators in Asia to have ear loops and NIOSH states that “limited assessment of ear loop designs indicate difficulty achieving a proper fit. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved.” Source: CDC.
-
This design tends to fit people with facial features common in China and other countries in Asia and may not be able to achieve a satisfactory fit for all customers users. To provide the expected level of protection, this respirator must be fit tested as part of an overall respiratory protection program in accordance with requirements under OSHA Respiratory Protection standard (29 CFR 1910.134) to ensure that it seals to the wearer’s face, without allowing air leaks to pass through gaps between the respirator and the wearer’s skin. In addition, individuals should read and follow all user instructions, including conducting a user seal check every time they put on a respirator. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator.
-
Note 4: This respirator is not suitable for use in a sterile field or in environments with exposure to high velocity splashes, sprays, or splatters of blood or body fluids, such as in operative or procedural settings. The CDC recommends the use of a Surgical N95 in these settings and a level 3 fluid resistance is required for FDA approval of a surgical N95 respirator. If using in a surgical environment due to a lack of alternatives, it is recommended that you use a face shield approved for medical use with this respirator.
-
Note 5: Tested against Chinese standards by laboratories that are ISO/IEC 17025 accredited, by a test lab accredited to act as a notified body for Regulation (EU) 2016/425 Personal protective equipment The European Union Commission website provides a link to the list of Notified Bodies for Personal Protective Equipment in Europe – bodies notified under Regulation (EU) 2016/425 on personal protective equipment. Our on-the-ground team conducts engineering, evaluation, development, production, quality control and quality assurance. We have also validated this product for regulatory compliance, working with a team of regulatory consultants and lawyers with decades of experience conducting medical device reviews with the FDA.
- Not made with latex rubber
|