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510(k) Data Aggregation
(113 days)
3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure 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 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile.
This document is a 510(k) Summary for the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a detailed "Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3" table. This table serves as the primary source for acceptance criteria and the reported performance of the subject device.
| Acceptance Criterion (Test) | Acceptance Limit (Requirement) | Subject Device Performance (3M™ High Fluid-Resistant Surgical Mask & 3M™ High Fluid-Resistant Procedure Mask) | Predicate Device Performance (Kimberly-Clark* KC300 Surgical Mask (K131879)) |
|---|---|---|---|
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥98% @ 0.1 micron | 32/32 Passed at ≥98% @ 0.1 micron | Pass at ≥98% @ 0.1 micron |
| Fluid Resistance (ASTM F1862) | 160mm Hg | 32/32 Passed at 160mm Hg | Fluid Resistant 160mm Hg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% | 31/32 Passed at ≥98% | Pass at ≥98% |
| Differential Pressure (MIL-M36954C) |
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