(114 days)
Surgical Face Mask is 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 is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The ear loops, which are made of nylon and spandex, are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
The provided text is a 510(k) Summary for a Surgical Face Mask. It details the non-clinical tests performed to demonstrate the device meets acceptance criteria and is substantially equivalent to a predicate device.
Here's the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document references ASTM F2100-2019 Level 2 requirements as the acceptance criteria for several performance parameters.
| Acceptance Criteria (ASTM F2100 Level 2) | Reported Device Performance (Proposed Device K202904) |
|---|---|
| Fluid Resistance: Pass at 120 mmHg | Pass at 120 mmHg |
| Particulate Filtration Efficiency (PFE): ≥ 98% at 0.1µm | Average 98.74% at 0.1µm |
| Bacterial Filtration Efficiency (BFE): ≥ 98% | Average 99.65% |
| 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.