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510(k) Data Aggregation
(90 days)
The WYZ Surgical Mask is 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 a single use, disposable device(s), provided non-sterile.
The proposed device (model: WYZ201) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed devices are manufactured with three layers, the inner and outer layers are made of Polypropylene (PP) spun-bond, and the middle layer is made of Polypropylene (PP) melt-blown. The WYZ201 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic film based on styrene block copolymer (SBC) with polyolefin (PO) outer layer. Hotmelt based on styrene-isoprene block copolymers (SIS) Nonwoven on both sides based on polypropylene (PP) spun-bond. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Galvanized iron wire with PP+PE coating. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
Here's an analysis of the provided text regarding the WYZ Surgical Mask (K211576), focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are presented in the "Non-Clinical Test Conclusion" section (pages 6-7).
| Test Item | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | PASS |
| 3 non-consecutive lots tested, using a sample size of 32/lot. | ||
| 32 out of 32 pass at 120 mmHg | ||
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | PASS |
| 3 non-consecutive lots tested, using a sample size of 32/lot. | ||
| Lot1: 99.82% | ||
| Lot2: 99.78% | ||
| Lot3: 99.72% | ||
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | PASS |
| 3 non-consecutive lots tested, using a sample size of 32/lot. | ||
| Lot1: 99.92% | ||
| Lot2: 99.84% | ||
| Lot3: 99.86% | ||
| Differential Pressure (Delta P) (EN 14683 Annex C) |
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