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510(k) Data Aggregation
(88 days)
The Disposable surgical masks are intended to be worn to protect 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 surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (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 elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 3 non-consecutive lots tested: All passed (implied) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9% | Pass |
| Differential Pressure (MIL-M-36954C) |
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(110 days)
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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 proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have 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 Polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown cloth. 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 Elastic materials consisting of Nylon low elastic yarn 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 and galvanized iron wire plastic materials. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The document describes the non-clinical performance testing of a disposable surgical mask to demonstrate its substantial equivalence to a predicate device, rather than a study involving an AI-powered device or human readers. Therefore, much of the requested information regarding AI assistance, human readers, effect size, and ground truth establishment for AI models is not applicable to this document.
However, I can provide information based on the performance testing of the surgical mask.
1. A table of acceptance criteria and the reported device performance
| Item | Reported Device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 31 out of 32 Pass at 120 mmHg | 29 out of 32 Pass at 120mmHg | PASS |
| Particulate Filtration Efficiency ASTM F2299 | 99.4% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | 99.36% | ≥ 98% | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | 4.43mmH2O/cm² |
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