(145 days)
The Medical 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. This is a single use, disposable device(s), provided non-sterile.
The Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The Medical Face Masks are single use, disposable device, provided non-sterile.
The provided text describes the acceptance criteria and the study conducted for "Medical Face Masks" (K202627).
Here's the extracted information:
-
Table of Acceptance Criteria and Reported Device Performance:
Methodology/Standard Purpose Acceptance Criteria Reported Device Performance ASTM F1862M-17 Fluid Resistance Performance 29 out of 32 pass at 120mmHg 29 out of 32 pass at 120mmHg ASTM F2299 Particulate Filtration Efficiency ≥98% Average 99.82% at 0.1μm ASTM F2101-19 Bacterial Filtration Efficiency ≥98% Average 99.78% EN 14683:2019 Annex C 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.