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510(k) Data Aggregation
(111 days)
The Surgical Face Mask is intended for single use by operation room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.
This document is a 510(k) Premarket Notification for a Surgical Face Mask. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in AI/ML medical device submissions. However, this document is for a physical medical device (a surgical face mask), not an AI/ML device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable and are not present in the provided text.
This document focuses on the performance of the surgical face mask based on established ASTM and ISO standards for biocompatibility and barrier protection.
Here's a breakdown of the available information based on your request, with a clear indication of what is not applicable for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides two tables: "Table 1 Summary of Biocompatibility Test Results" and "Table 2 Summary of Performance Testing".
Table 1: Summary of Biocompatibility Test Results
| Test/Purpose | Test Method/Standard | Acceptance Criteria | Result |
|---|---|---|---|
| In Vitro Cytotoxicity Test | ISO 10993-5: 2009 | Reduction of cell viability shall be not more than 30%. | Passed: No Cytotoxicity Observed |
| Skin Sensitization Test | ISO 10993-10: 2010 | The skin reactions grades shall be less than 1. | Passed: No Skin Sensitization Observed |
| Skin Irritation Test | ISO 10993-10: 2010 | The irritation response category shall be slight or less. | Passed: No Skin Irritation Observed |
Table 2: Summary of Performance Testing (for Level 2 Mask - as per ASTM F2100-19)
| Performance Test/Purpose | Test Standard | Acceptance Criteria | Test Results (Lot #1) | Test Results (Lot #2) | Test Results (Lot #3) |
|---|---|---|---|---|---|
| Bacterial Filtration | ASTM F2101-2019 | Level 2: >98% | MIN: 98.99% AVG: 99.53% | MIN: 98.46% AVG: 99.10% | MIN: 98.36% AVG: 99.2% |
| Differential Pressure | EN 14683 Annex C | Level 2: 98% | MIN: 98.99% AVG: 99.58% | MIN: 98.30% AVG: 99.25% | MIN: 98.45% AVG: 99.11% |
| Resistance to Penetration | ASTM F1862/F1862M-17 | Level 2: 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg |
| Seal strength of immediate package | ASTM F88/F88M-15 | Seal strength >= 2N/15mm | MIN: 2.2 AVG: 3.04 | MIN: 3.2 AVG: 3.54 | MIN: 2.2 AVG: 2.9 |
| Seal leak of immediate package | ASTM F1929-15 | No apparent solution channel through the whole seal edge in the whole seal area | No | No | No |
| EO ECH Residue | ISO 10993-7:2008 | EO residue |
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