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510(k) Data Aggregation
(112 days)
Surgical Face Masks (Ear Loops And Tie-On)
The surgical face 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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.
| Test Parameter / Acceptance Criteria (per ASTM F2100-11) | Subject Device Performance (San-M Surgical Masks) | Predicate Device Performance (K160269) | Comparison |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | |||
| Level 1: Pass at 80 mmHg | Pass at 80 mmHg | Pass at 80 mmHg | Equivalent |
| Level 2: Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Equivalent |
| Level 3: Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Equivalent |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | |||
| $\ge 98%$ | Pass at 99.6% (all levels) | Pass at 99.6% (all levels) | Equivalent |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | |||
| $\ge 98%$ (Level 1, 2) | Pass at >98% (Level 1, 2) | Pass at >98% (Level 1, 2) | Equivalent |
| $\ge 99%$ (Level 3) | Pass at >99.9% (Level 3) | Pass at >99% (Level 3) | Equivalent |
| Differential Pressure ($\Delta$P) (MIL-M-36945C) | |||
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(217 days)
Surgical Face Masks (Ear loops and Tie-on)
The surgical face 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 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 Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.
Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance
| Test | Level 1 Acceptance Criteria (Per ASTM F2100-11) | Level 1 Reported Device Performance | Level 2 Acceptance Criteria (Per ASTM F2100-11) | Level 2 Reported Device Performance | Level 3 Acceptance Criteria (Per ASTM F2100-11) | Level 3 Reported Device Performance |
|---|---|---|---|---|---|---|
| ASTM F1862 (Fluid Resistance) | Pass at 80 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 160 mmHg |
| ASTM F2299 (Particulate Filtration Efficiency) | ≥ 95% | Pass at 99.6% | ≥ 95% | Pass at 99.6% | ≥ 98% | Pass at 99.7% |
| ASTM F2101 (Bacterial Filtration Efficiency) | ≥ 95% | Pass at >98% | ≥ 95% | Pass at >98% | ≥ 98% | Pass at >99% |
| MIL-M36945C (Differential Pressure) |
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