(196 days)
The 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 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/sterile.
The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering. In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer). The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices. The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.
This document primarily concerns the regulatory approval (510(k) clearance) of a medical device, specifically a Disposable Surgical Face Mask, by the FDA. The information provided heavily focuses on non-clinical performance testing against established standards, rather than the type of clinical study involving human-in-the-loop performance or expert consensus typically found in AI/CADe device submissions.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available within this document because the device is a physical product (a face mask) and its evaluation relies on established material and performance standards, not on image interpretation or diagnostic algorithms.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Disposable Surgical Face Mask
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements for Level 3 as specified in ASTM F2100-19 and other relevant standards.
| Test (Standard) | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Performance (Disposable Surgical Face Mask) | Reported Performance (Disposable Surgical Mask (Sterile)) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Pass at 160 mmHg | 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.5%~99.7% (Average: 99.6%) | 99.7%~99.9% (Average: 99.8%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.37%~99.99% (Average: 99.74%) | 99.32%~99.85% (Average: 99.63%) |
| Differential Pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. |
§ 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.