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Surgical Masks and Respirators: 21 CFR (FDA) Surgical masks sold in the US are regulated under 21 CFR Section 878.4040: Surgical apparel by the FDA. According to the definition provided by the FDA, surgical masks are intended to protect both the wearer and the patient from microorganisms, body fluids, and others.

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There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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Moldex: Innovative Respiratory Masks & Hearing Protection . CBRN Warning · Recall Information · Informational Links · ISO 9001 2015 UL DQS Certificate · Material Safety Data Sheets Moldex-Metric, Inc. was established in 1980 and is a US-based privately held disposable white respirator face mask Moldex has taken a leadership position among global PPE manufacturers in

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When to Use a Surgical Face Mask Wear a surgical face mask in a cohorted area such as cleaning a room, cleaning equipment, discharging patient rooms, etc. Close contact with patients such as providing them with patient care, direct home care visits, diagnostic imaging, phlebotomy services, etc. When to Use a Respirator FFP3 Mask

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The masks can be made by different manufacturers and won’t all have the same specifications, but they will all have to meet those minimum standards. Wearing an FFP3 mask, you’ll be protected from inhaling solid particles, non-volatile liquid particles and oil-based mists. FFP3 face masks are the standard that the NHS demands for its staff.

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