(272 days)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.
This document is a 510(k) summary for a Disposable Surgical Mask (K202580), comparing it to a predicate device (DemeMASK, K201479). The information provided focuses on non-clinical performance testing to demonstrate substantial equivalence, rather than a study involving an AI-powered medical device or human readers.
Therefore, many of the requested details related to AI performance, human reader studies, and expert adjudication are not applicable to this document. The device in question is a physical product (surgical mask), not a diagnostic algorithm or imaging system requiring such analyses.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Reported Device Performance (Disposable Surgical Mask) | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | 32 out of 32 passed in 160 mm Hg | 29 out of 32 passed in 160 mm Hg | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299) | ≥99% | ≥98% | Pass |
| Bacterial filtration efficiency (ASTM F2101-19) | ≥99% | ≥98% | Pass |
| Differential pressure (MIL-M-36954) | Average 3.7 mmH₂O/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.