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The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.

The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.

Here's a breakdown of the acceptance criteria and study information for the "MEDICAL FACE MASKS, Model Name: MY020003" based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The Medical 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 practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The Medical Face Masks are single use, disposable device, provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for "Medical Face Masks" (K202627).

Here's the extracted information:

1. Table of Acceptance Criteria and Reported Device Performance:

   Methodology/Standard	Purpose	Acceptance Criteria	Reported Device Performance
   ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 120mmHg	29 out of 32 pass at 120mmHg
   ASTM F2299	Particulate Filtration Efficiency	≥98%	Average 99.82% at 0.1μm
   ASTM F2101-19	Bacterial Filtration Efficiency	≥98%	Average 99.78%
   EN 14683:2019 Annex C	Differential Pressure

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