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KP100 facemask for FDA certification

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Enforcement Guidance for Use of Respiratory Protection ...

Apr 03, 2020 · Certification in accordance with these standards ensures that devices provide similar filtration as NIOSH-certified equipment, as described in Tables 1 and 2, below, and, accordingly, have an assigned protection factor greater than or equal to 10. Enforcement Guidance

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If you have a product you believe is NIOSH-approved and FDA-cleared that does not appear on this list, you will need to check with the FDA Center for Devices and Radiological Health at 1-800-638-2041 for validation of clearance. N95 –N95 – Filters at least 95% of airborne particles. Not resistant to oil.

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Certification in accordance with these standards ensures that devices provide similar filtration as NIOSH-certified equipment, as described in Tables 1 and 2, below, and, accordingly, have an assigned protection factor greater than or equal to 10. Enforcement Guidance

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