(86 days)
The Surgical 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, provided non-sterile.
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.
This document describes the performance testing for the Bain Medical Equipment (Guangzhou) Co., Ltd. Surgical Masks (K203524).
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test / Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M-17) | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (ASTM F2101-2019) | To determine the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of Staphylococcus aureus. | ≥98% | Average 99.9% |
| Particulate Filtration Efficiency (ASTM F2299/F2299M-03 (2017)) | To determine the Particle Filtration Efficiency of materials used in medical face masks to penetration by particulates using latex spheres. | ≥98% | Average 98.8% |
| Differential Pressure (EN 14683:2019) | To determine the 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.