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N95 Respirators and Surgical Masks (Face Masks) FDA

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 creates a physical barrier between...

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Surgical Mask and Gown Conservation Strategies - fda.gov

The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and …

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FAQs on Shortages of Surgical Masks and Gowns FDA

Surgical masks? The FDA is aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be stressed if demand exceeds available supplies.

Product Classification - Food and Drug Administration

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus; 6-406 ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Surgical Masks - U.S. Food and Drug Administration

The surgical masks referenced in this guidance document include masks that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without a face shield.

Masks and N95 Respirators FDA

All FDA-cleared N95 respirators are labeled as "single use", disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator,...

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Most Class 1 medical device can be self Certified by EU MDR or even as per US FDA regulations. Class 1 Medical Device, CE marking, Notified Body involvement is not mandatory. Class 1 products manufactures ISO 13485 implementation and certification is not required. Minimum level of GMP compliance is recommended.

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