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N95 Respirators, Surgical Masks, and Face Masks | FDA

2020-8-13 · The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use. A surgical mask is a loose-fitting, disposable device that …

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2020-7-29 · Answers to frequently asked questions about face masks and surgical masks, including manufacturing, purchasing, importing, donating masks during the COVID-19.

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BFE (bacterial filtration efficiency) measures how well the mask filters out bacteria when challenged with a bacteria containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. aureus (average size 0.6 0.8 microns). In order to be called a medical/surgical mask, a minimum 95% filtration rate is required.

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2020-9-11 · Mask standards can be confusing: N95, KN95, FFP1, P2, or surgical mask? This quick run-down covers mask types, mask ratings, and their effectiveness at filtering particles. First off, let’s start with mask types (or certification types). In general, there are 3 (or sometimes 4) types of commonly used, disposable masks.

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2020-6-15 · Surgical mask manufacturers or importers are required to submit a 510(k) premarket notification to gain the FDA’s clearance to import and sell the products in the USA. There is a 90 lead time between submitting the 510(k) and being able to place the products on the market.

How Surgical Masks are Made, Tested and Used

Surgical Mask Tests. Once surgical masks are made, they must be tested to ensure their safety in various situations. There are five tests they must be put through: Bacteria filtration efficiency in vitro (BFE). This test works by shooting an aerosol with staphylococcus aureus bacteria at the mask at 28.3 liters per minute.

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