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510(k) Data Aggregation
(162 days)
The Single-use medical face mask is 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, provided nonsterile.
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven 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 not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the FDA 510(k) clearance for a "Single-use medical face mask" (Model: HD0969). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for medical face masks.
| Test Methodology | Purpose | Acceptance Criteria for Level 3 | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|---|---|
| Fluid Resistance Performance (mmHg) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS (Average of 3 batch numbers: 160mmHg) | Yes |
| Particulate Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 98.79%) | Yes |
| Bacterial Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 99.87%) | Yes |
| Differential Pressure (mmH2O/cm²) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. |
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(235 days)
Single-use medical face mask is 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 proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Methods | Reported Device Performance | Acceptance Criteria |
|---|---|---|---|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19 / ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron (%) | ASTM F2100-19 / ASTM F2299 / ASTM F2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19 / ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-19 / 16 CFR Part 1610-2019 | NA (result implicit Class 1) | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19 / EN 14683:2019+AC:2019(E) Annex C | Average 2.44 | Level 1: |
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