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510(k) Data Aggregation
(470 days)
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.
The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G 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 non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the 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 is made of malleable polyethylene with Galvanized iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.
The provided text is related to the FDA 510(k) clearance for a surgical mask. It details the device description, intended use, and a comparison of technological characteristics and performance between the subject device and a predicate device.
However, the questions you've asked about "acceptance criteria and the study that proves the device meets the acceptance criteria" are typically associated with artificial intelligence (AI) or machine learning (ML) medical devices, which involve performance evaluation against ground truth established by experts.
The document provided is for a physical medical device (a surgical mask) and its performance is evaluated against established physical and biological standards (e.g., fluid resistance, bacterial filtration efficiency, flammability, biocompatibility). It does not involve AI/ML performance metrics, expert adjudication, or MRMC studies.
Therefore, I cannot answer your specific questions based on the provided text, as they are not relevant to the type of device and study described in the FDA 510(k) submission for a surgical mask.
To give a complete answer, I would need a document related to an AI/ML medical device submission.
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(127 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
This document describes the premarket notification (510(k)) for the BASE4 Disposable Medical Mask, outlining its acceptance criteria and the studies performed to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Reported Device Performance | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 31 out of 32 pass at 80 mm Hg; 30 out of 32 pass at 120 mm Hg | 29 out of 32 pass at 120 mm Hg | Pass (Level 2) |
| Particulate Filtration Efficiency (ASTM F2299) | 98.8% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | > 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) MIL-M-36954C | 4.4 mmH2O/cm² |
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