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Surgical Masks - Premarket Notification [510(k)] Submissions This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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510K Summary. 510(k) for ASTM F2100 Level 2 and Level 3 Face Mask(s) OC 202011o. 510K Summary. Date Summary was May 17, 2011 Prepared: 610(k) Submitter: Ann Waterhouse, RAC Associate Director of Regulatory Affairs Roswell, GA 30076 678-352-671 9 (telephone) 920-225-3108 (facsimile) Ann.waterhouse(&kcc Device Trade Name: KG 200 Face Mask KG 300 Face Mask …

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WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of I100% mneltblown polypropylene filter media0 Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire.

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