(45 days)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The 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(s), provided non-sterile.
The surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided FDA 510(k) summary for the "Surgical Face Mask" (K202277) details performance testing against established acceptance criteria for medical face masks. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria for Level 2 Mask | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Particulate Filtration Efficiency (PFE, at 0.1µm, %) ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure (Delta P, mm H2O/cm²) ASTM F2100-19 EN 14683:2019, Annex C |
§ 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.