(202 days)
The medical 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 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of the proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of knitted elastic loops (made of nylon and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a galvanized wire with polyethylene covering. The proposed device is provided non-sterile and is intended to be a single use, disposable device.
This document describes the premarket notification (510(k)) for a Medical Surgical Mask (Non-sterile). The acceptance criteria and performance study details are provided in the "Non-clinical Testing" section, specifically in Table 2 "Performance Testing" and Table 3 "Biocompatibility Testing".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical surgical mask and its performance is evaluated against the ASTM F2100-19 standard for materials used in medical face masks. The acceptance criteria are specified for Level 1, Level 2, and Level 3 requirements, and the device reports performance that meets all these levels.
| Test | Purpose | Acceptance Criteria (ASTM F2100-19) | Reported Device Performance (Statistics of three lots) | Verdict |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥29 out of 32 pass at 80 mmHg | 32 out of 32 pass at 80 mmHg | Pass |
| Level 2: ≥29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass | ||
| Level 3: ≥29 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Pass | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify that bacterial filtration efficiency of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥95% | 99.56%~99.99% | Pass |
| Level 2: ≥98% | (Same as above) | Pass | ||
| Level 3: ≥98% | (Same as above) | Pass | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify that particulate filtration efficiency of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥95% | 98.07%~99.24% | Pass |
| Level 2: ≥98% | (Same as above) | Pass | ||
| Level 3: ≥98% | (Same as above) | Pass | ||
| Differential Pressure (Delta-P) (EN 14683) | Verify that differential pressure of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: |
§ 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.