(109 days)
The 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Face Masks are single use, disposable devices, provided non-sterile.
Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.
There are two models for Face Mask with different colors and sizes.
For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.
The provided text describes the acceptance criteria and performance data for a medical device (Face Mask) in the context of an FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.
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 | Acceptance Criteria (Predicate/Reference Device Performance) | Reported Device Performance (Subject Device) | Remark |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 32 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | Same |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Pass at 99.88% (Predicate), >99.8% (Reference) | Pass at 99.70% | Same (Meets general acceptance for high filtration) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Pass at 99.6% (Predicate), $\ge$ 99.8% (Reference) | Pass at 99.95% | Same (Meets general acceptance for high filtration) |
| Differential Pressure (Delta P) (MIL-M-36954C) | Pass at 3.0 mmH$_2$O/cm$^2$ (Predicate), |
§ 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.