(109 days)
The non-sterile disposable medical face masks are 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, provided non-sterile.
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.
Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.
This document describes a 510(k) premarket notification for "Disposable Medical Face Masks" (K202719) by Jiangxi Sanxin Medtec Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Disposable Medical Face Masks are based on Level 2 requirements of the ASTM F2100:2019 standard. The study demonstrates that the proposed device meets these requirements.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (ASTM F2100:2019 Level 2) | Proposed Device Performance (Non-sterile) | Proposed Device Performance (Sterile) |
|---|---|---|---|
| Fluid resistance | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Average 98.17% | Average 98.14% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | Average 98.38% | Average 98.64% |
| 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.