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BRS Procedure Face Mask is a non-sterile, single use, disposable face mask intended to be worn to protect both healthcare personnel and patients from the transfer of microorganisms, blood and body fluids, and particulate material. This equipment is intended for the use in infection control practices to reduce the potential exposure to blood and fluids.

BRS Level 1 Procedure Face Mask (Model# 00850021617004)
BRS Level 2 Procedure Face Mask (Model# 00850021617196)
BRS Level 3 Procedure Face Mask (Model# 00850021617561)

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The provided document is a 510(k) premarket notification letter from the FDA for a surgical face mask (BRS Procedure Face Mask). It is a regulatory approval document and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Initial 510(k) clearance: Stating the device is substantially equivalent to legally marketed predicate devices.
• Regulatory compliance reminders: Information about general controls, specific regulations, registration, labeling, adverse event reporting, and quality systems.
• Indications for Use: Clearly defining the intended purpose of the BRS Procedure Face Mask.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study from this document, as it does not contain that type of technical performance data.

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