(60 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and polyester. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document pertains to the 510(k) premarket notification for a Medical Face Mask, and as such, it describes performance testing for a physical medical device, not software or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate it meets those criteria.
Acceptance Criteria and Device Performance for Ammex-Weida (Hubei) Health and Safety Products Co., Ltd's Medical Face Mask
The device under review is a Medical Face Mask, a physical device, not an AI/algorithm-based one. The acceptance criteria are based on established performance standards for medical face masks.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Medical Face Mask (Proposed Device, K211062)
Classification: Class II, ASTM F2100 Level 3 (meets Level 3 requirements)
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 160 mmHg | 32 out of 32 Pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
§ 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.