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510(k) Data Aggregation
(203 days)
The Disposable Medical 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The provided text describes the 510(k) summary for a Disposable Medical Mask (Model: Rlp001) seeking substantial equivalence to a predicate device (3M™ High Fluid-Resistant Procedure Mask, K191355). The acceptance criteria are based on recognized performance standards for medical face masks.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item (Performance Level 3) | Test Method | Acceptance Criteria | Reported Device Performance / Verdict |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Differential pressure (Delta-P) | EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019 |
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