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Surgical Masks - Premarket Notification [510(k ...

In an Abbreviated 510(k), FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you ...

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Facemasks and N95 respirators are examples of personal protective equipment that are used to protect the wearer from liquid and airborne particles contaminating the face. They are one part of an ...

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PPE | Mantis Medical Compliance

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Guide to Face Mask Selection and Use

Levels for Surgical Masks= ASTM LEVEL 2 ... NIOSH Approved N95 Particulate Respirator High Fluid Resistance 160 mmHg Filtration Efficiency Meets CE 0121 – In reference to EN 149: 2001 FFP2 NR. ... • Protects mask and face from direct splatter; may prolong mask life. • Sonically welded elastic headband for added strength.

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CFR - Code of Federal Regulations Title 21

Apr 01, 2019 · (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

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