(164 days)
The 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. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Surgical Face Mask is 4 ply Flat Pleated type mask, utilizing ear loops for wearing, and it has nose band design for fitting the face mask around the nose. The Surgical Face Mask is manufactured with four layers. The first and second layers are made of polypropylene (PP) non-woven fabric with green coloration. The third layer has filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The fourth layer (inner layer) contacting with face is made of polypropylene (PP) non-woven fabric without color. The functions of the four layers are as follows, 1st Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 2nd Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 3rd Layer: Electrostatic-induced melt-blown polypropylene, blocks dust and microbes. 4th Layer: PP non-woven fabric, provides soft feel and reinforces spray and droplet protection. The Surgical Face Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon. The nose band, made of steel wire coated with Polyethylene resin, contained in the subject device is in the layers of face mask to allow the user to fit the face mask around their nose. The Surgical Face Masks are sold non-sterile and are intended to be singleuse. The size of the face mask is 175 mm * 95 mm.
This document describes the non-clinical performance testing of the "Surgical Face Mask" manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd. (K212863), to demonstrate its substantial equivalence to a legally marketed predicate device (K201549).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Test method (Performance Level 3) | Purpose | Acceptance criteria (ASTM F2100-20) | Reported Device Performance (Test results / Verdict) |
|---|---|---|---|---|
| 1 | EN 14683:2019+AC:2019(E), Annex C | Evaluate the mask's resistance to airflow across the face mask (Differential pressure, Delta-P) | Section 9.2: |
§ 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.