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510(k) Number (if known) K182514 Device Name Disposable Surgical Face Mask Indications for Use (Describe) The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infectionIvy Wang - Food and Drug Administration510(k) Number (if known) K182515 . Device Name Surgical Face Mask . Indications for Use (Describe) The Surgical Face Masks are intended to be worn to protect both the patient and healthcare disposable fda 510k face maskGuidance on Surgical Masks - Premarket Notification Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004.

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FDA 510(k):K141875. US FDA APROVAL Class II FDA Classification Panel: General and Plastic Surgery. Bacterial Filtration Efficiency (BFE): 99.76% with 3.0m, bio-aerosol particles Particulate Filtration Efficiency (PFE): 99% for particles at 0.1m Differential Pressure (DP): 3.33mm H2O/cm2 Breathability (DP): Ezy-Breathe Technology Fluid Resistance: Resists Synthetic Blood @ 80mm Hg disposable fda 510k face maskDisposable 3-Ply Face Mask FDA-Registered (20 Pack)20-Pack of FDA-Registered, 3-ply disposable face masks with bidirectional pleats, and bendable nose strip for comfort. One size fits all. Due to the nature of this product, all sales are final and returns cannot be accepted. Key Features: Sold in packs of 20 masksDisposable 3-Ply Face Mask FDA-Registered (20 Pack)20-Pack of FDA-Registered, 3-ply disposable face masks with bidirectional pleats, and bendable nose strip for comfort. One size fits all. Due to the nature of this product, all sales are final and returns cannot be accepted. Key Features: Sold in packs of 20 masks

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Ivy Wang - Food and Drug Administration

510(k) Number (if known) K182515 . Device Name Surgical Face Mask . Indications for Use (Describe) The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practicesDisposable FDA 510K/EN14683 Elastic Earloop Medical Mask, Face Mask, Surgical Mask manufacturer / supplier in China, offering Disposable FDA 510K/EN14683 Elastic Earloop Medical Face Masks, Disposable Air Respirator Smoke Protection Face Mask, ASTM Level 2 Surgical Mask FDA 510K Bfe 99% Earloop and so on.510K Summary - Food and Drug AdministrationMay 17, 2011 · 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 disposable fda 510k face mask

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This Medical Disposable Masks generally will last about 4-8 hours depending on the using environment. Such as in the Hospital, The Max using time is 4 Hours. Standards and Certifications: FDA CE . How to use our masks: 1. Open the mask. 2. The dark color

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