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510(k) Data Aggregation
(169 days)
The Surgical 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 Surgical Face Mask is composed of mask body, nose clip and ear loops. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex. The size of the Surgical Face Mask is 17.5*9.5cm with tolerance ± 5% cm, the length of the ear loopis 16cm, and the length of the nose clip should no less than 8.0cm. The outer layer of Surgical Face Mask will be provided in blue, the inner layer of the Surgical Face Mask will be provided in white. The Surgical Face Mask will be provided non-sterile and is intended to be single use.
The document describes the non-clinical performance testing of a Surgical Face Mask (Trade/Device Name: Surgical Face Mask, Model: TY123, K212059) to demonstrate its substantial equivalence to a legally marketed predicate device (K182514).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Subject device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | No penetration at 120 mmHg | No penetration at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | >99.16% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) EN 14683 Annex C |
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