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510K Summary - Food and Drug Administration

510(k) for ASTM F2100 Level 2 and Level 3 Face Mask(s) KC300 face mask(s) is a s ingle use, disposable device(s), provided non-sterile. Technological The Kimberly-Clark KC200 and K C300 face mask(s) are Characteristics and substantially equivalent to the predicate device, Kimberly-Clark

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Surgical Masks - Premarket Notification [510(k ...

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. Surgical ...

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Disposable Facemasks Kimberly-Clark Professional™ THE LITE ONE™ Surgical Mask Features a protective three-layer construction for adequate protection …

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Surgical mask . A surgical mask, also known as a procedure mask, medical mask or simply as a face mask, [1] [2] is intended to be worn by health professionals during surgery and during nursing to catch the bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose.s from the wearer's mouth and nose.

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General: Brand: None Type: Mask Model: None Color: Blue. Specification: Product: Medical Face Masks, 3ply. Intended Use: The intended use of a medical face mask is to help prevent large particles expelled by the wearer(e.g.split,mucous) from reading the patient or work envirconment.Fluids contacting the outer surrface of the surgical mask will not immediately soak through to the interior of ...

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Our Surgical Masks meet EN14683 standard of EU, and also have acquired FDA 510(K). The sales headquarter is located in Guangzhou City and manufacturing plant covers an area of 6,000 square meters among which a 1,200 square meters of clean room is included.

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510(K) Premarket Notification - accessdata.fda.gov

Dec 13, 2004 · APPRIVA MEDICAL, INC. k002054: 02/16/2001: abl-700 series, model abl 7xx (various models) RADIOMETER MEDICAL A/S k002290: 09/13/2000: spectrum 2 reusable full face mask, model 1004884 and 1004876: RESPIRONICS, INC. k002465: 09/08/2000: dideco micro 40 ph.i.s.i.o (phosphorylcholine insert surface in oxgenation) newborn/infant arterial filter

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Surgical mask . A surgical mask, also known as a procedure mask, medical mask or simply as a face mask, [1] [2] is intended to be worn by health professionals during surgery and during nursing to catch the bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose.s from the wearer's mouth and nose.

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