(88 days)
The Disposable 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 Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): |
§ 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.