K Number
K212235
Date Cleared
2021-12-06

(140 days)

Product Code
Regulation Number
878.4040
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Surgical 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. Surgical Face Masks are single use, disposable devices, provided non-sterile.

Device Description

Surgical Face Mask contains one model called YOD2001. YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type. YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of polypropylene to provide a firm fit over the nose.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Surgical Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and effect size) are not applicable or provided in this document.

However, I can extract information related to the performance testing of the physical surgical mask against established standards.

Acceptance Criteria and Device Performance (for the physical mask):

The acceptance criteria are derived from ASTM F2100 - Level 2 standards. The reported device performance indicates that the Surgical Face Mask met all these criteria.

Performance CharacteristicsTest MethodAcceptance Criteria (Level 2)Reported Device Performance
Bacterial Filtration Efficiency (BFE)ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus≥98%Pass
Differential Pressure (Delta-P)EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019

§ 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.