(124 days)
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.
| Acceptance Criteria (ASTM 2100 Level 2) | Reported Device Performance (AOK 95A Medical Mask) |
|---|---|
| Fluid resistance: Pass at 120mmHg | Pass at 120mmHg |
| Particulate efficiency level: ≥98% | ≥98% |
| Bacterial filtration level: ≥98% | ≥98% |
| Differential pressure: |
§ 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.