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510(k) Data Aggregation
(116 days)
Nantong Taiweishi Medical Technology Co., Ltd.
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 sterile.
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the facemask. The loops are made of Nylon and spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
The provided text describes the non-clinical performance testing for a surgical face mask (Trade Name: Surgical Face Mask, Model: Earloop17.5*9.5cm, K212264) to demonstrate its substantial equivalence to a predicate device (Kimberly-Clark KC100 Mask, K110455).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 2) | Result of LOT-WK20201006 | Result of LOT-WK20201204 | Result of LOT-WK20201208 |
|---|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C, ASTM F2100-19) |
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(90 days)
Nantong Taiweishi Medical Technology Co., Ltd.
The Surgical Face Mask (non-sterile) 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(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The 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 nylon and spandex. 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 polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
Here's a breakdown of the acceptance criteria and study information for the "Surgical Face Mask (non-sterile)" as presented in the FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 2) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.16% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.74% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
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