(154 days)
The Disposable Surgical Face 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(s), provided non sterile.
The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | ASTM F2100 Level (if applicable) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862M-17) | 160 mmHg (Level 3) | 95 of 96 samples passed at 160mmHg | Level 3 |
| Particulate Filtration Efficiency (PFE) (ASTM F2299-03) | ≥98% | 96/96 samples passed at ≥98% | Level 3 |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥98% | 94/96 samples passed at ≥98% | Level 3 |
| Differential Pressure (EN 14683 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.