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510(k) Data Aggregation
(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: |
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