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The AOK 95A Medical Mask (20200049) is 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 AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is sold non-sterile and are intended to be single use, disposable devices.

This document describes the safety and effectiveness of the AOK 95A Medical Mask (K220876) by comparing it to a legally marketed predicate device (AOK Tooling Limited - K211956). The evaluation relies on non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance

The table below summarizes the acceptance criteria and the reported performance of the AOK 95A Medical Mask. These criteria are based on ASTM 2100 Level 2 standards.

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