(119 days)
The medical face masks are intended to be worn to protect both the patient and healthcare persomel 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, provided non-sterile.
The Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile.
This document is a 510(k) summary for a Medical Face Mask (K212994) by Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. It compares the proposed device to a predicate device (K160269) to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical performance characteristics evaluated, their acceptance criteria, and the reported results for the proposed device (Level 3 mask, as Level 1, 2, and 3 are physically the same) are presented in the following table:
| Performance Characteristics | Test Method | Reported Device Performance | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862/F1862M: 2017 | Pass at 160 mmHg | No penetration at 160 mmHg | Meet the requirement |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 (2017) | Pass at 99.2% | ≥98% | Meet the requirement |
| Bacterial Filtration Efficiency | ASTM F2101: 2019 | Pass at 99.2% | ≥98% | Meet the requirement |
| Differential Pressure (Delta-P) | EN 14683: 2019, Annex C | Pass at 3.8 mm H2O/cm² |
§ 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.