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510(k) Data Aggregation
(230 days)
Disposable Medical Surgical Face Mask
Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
Disposable Medical Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.
The provided document describes the acceptance criteria and the study that proves the performance of a Disposable Medical Surgical Face Mask.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Item | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Level 3: 160 mm Hg | All samples met the predetermined acceptance criteria. |
| Bacterial Filtration Efficiency (BFE) | ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | ≥ 98% | All samples met the predetermined acceptance criteria. |
| Differential Pressure (Delta P) | ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks |
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(138 days)
Disposable Medical Surgical Face Masks
The Disposable Medical 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 Disposable Medical Surgical Face Masks are composed of mask body, nose clip and ear loop. The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of PE and iron wire, ear loop is made of Nylon and Spandex. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±1cm, the length of the ear loop is 18cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.
The provided document describes the acceptance criteria and study results for Disposable Medical Surgical Face Masks (K202211) manufactured by Guangdong Kaidi Garments Co., Ltd. The study focuses on demonstrating substantial equivalence to a predicate device (K153496) through non-clinical testing.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Level 2 Medical Mask) | Reported Device Performance (K202211) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | 32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot 1: 99.68%; Lot 2: 99.56%; Lot 3: 99.81% (3 non-consecutive lots tested) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% (3 non-consecutive lots tested) | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
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