Defender Safety’s Surgical Masks Earn FDA Clearance

May 18, 2021

Defender Safety, a personal protective equipment manufacturer based in Plainview, N.Y., has received FDA 510(k) clearance for three new surgical masks.

The firm earned marketing clearance for its American Society for Testing and Materials (ASTM) level 1 procedure mask, ASTM level 3 procedure mask and ASTM level 3 surgical mask.

ASTM level 1 is ideal for procedures that involve low risk of fluid exposure, while level 3 is intended for procedures that involve high risks of fluid exposure.

The company said that it tests its ASTM level 3 surgical masks for bacterial filtration efficiency, breathability, flammability and resistance to penetration by blood.

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