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510(k) Data Aggregation
(198 days)
The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The Disposable medical mask is flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clip design for fitting the facemask around the nose. The Disposable medical mask is only one model: WSKZ-001 and the color is blue. The Disposable medical mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue, CAS number: 147-14-8), and the middle layer is made of melt blown fabric. Ear loops, which is held to cover the users' mouth and nose by two Ammonium nylon elastic bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the Disposable medical mask is in the middle layer of Disposable medical mask to allow the user to fit the Disposable mask around their noses, which is made of Polypropylene and metallic iron. The Disposable medical mask is sold non-sterile and is intended to be single use, and the intended environment is professional healthcare facility environment. The shelf life of each Disposable medical mask is 2 years. The dimensions of each Disposable medical mask are length 175mm and width 95mm. The dimension of nose clip is length 100mm, and the ear loop is length 170mm.
The provided text describes the acceptance criteria and performance data for a medical mask (K203388) seeking FDA clearance, primarily through comparison to a predicate device (K153409).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 98% | ≥99.2% (Passed 32/32) |
| Differential Pressure (Delta-P) |
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(216 days)
Disposable Medical 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.
Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical 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 which are welded to the facemask. There are two types of ear loops for the disposable medical masks, one shaped in thin rope is made of Nylon and spandex, and the other shaped in narrow band is made of spun-bond polypropylene and elastic body. The ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polypropylene coating with iron wire. The medical masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
This is a 510(k) premarket notification for a Disposable Medical Mask (Model: Y01, Y02) and as such, it does not involve the use of AI. The provided document details the substantial equivalence of the proposed medical mask to a predicate device based on non-clinical performance and biocompatibility testing. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable.
Here's the information extracted from the document regarding the acceptance criteria and the study results for the medical mask:
1. Table of acceptance criteria and the reported device performance
| Item | Reported Device Performance (3 lots) | Acceptance Criteria (Level 1, as per ASTM F2100) | Result |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 32 out of 32 pass at 80 mmHg | ≥ 29 out of 32 pass at 80 mmHg | PASS |
| Particulate Filtration Efficiency ASTM F2299 | 99.12%, 99.45%, 99.56% | ≥ 95% | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | 99.92%, 99.93%, 99.92% | ≥ 95% | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | 3.0mmH2O/cm², 4.2mmH2O/cm², 3.7mmH2O/cm² |
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