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510(k) Data Aggregation
(454 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
The provided document is a 510(k) summary for a surgical face mask (K203161), demonstrating substantial equivalence to a predicate device (K202061). This type of regulatory submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and material comparisons. It does not contain information about a study involving human readers or AI assistance. Therefore, I will focus on the performance criteria and the non-clinical studies conducted for this device.
Here's the breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method | Acceptance Criteria | Reported Device Performance (Subject Device - 3 Lots) |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 (Resistance of Surgical face masks to penetration by synthetic blood) | (A) There are no burn times; or (B) There is only one burn time and it is equal to or greater than 3.5 seconds; or (C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. For the purpose of comparison to predicate, the reported criteria is 80 mmHg. | Lot 1: 32 Out of 32 pass at 80 mmHg |
| Lot 2: 32 Out of 32 pass at 80 mmHg | |||
| Lot 3: 32 Out of 32 pass at 80 mmHg | |||
| Particulate Filtration Efficiency (%) | ASTM F2299 (Initial Efficiency of Materials to Penetration by Particulates) | ≥ 95% | Lot 1: Average 96.6% |
| Lot 2: Average 96.1% | |||
| Lot 3: Average 96.2% | |||
| Bacterial Filtration Efficiency (%) | ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE)) | ≥ 95% | Lot 1: Average 99.5% |
| Lot 2: Average 99.4% | |||
| Lot 3: Average 99.4% | |||
| Flammability Class | 16 CFR 1610 (STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES) | Class 1 | Lot 1: Class 1 |
| Lot 2: Class 1 | |||
| Lot 3: Class 1 | |||
| Differential Pressure (Delta-P) (mm H2O/cm²) | ASTM F2100-19 / EN 14683:2019+AC (2019)(E), Annex C (Determine breathing resistance) |
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