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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.

The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

This document describes the acceptance criteria and the study results for the Guangdong Golden Leaves Technology Development Co., LTD's Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, 8862E), as presented in their 510(k) Summary (K223068).

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ASTM F2100 standard for Medical Face Mask Materials. All models (Level 1, Level 2, and Level 3) of the Medical Protective Mask are stated to meet the performance requirements of all three levels.

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