(182 days)
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)
Not Found
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.