(336 days)
The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Disposable Sterilized Latex Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5. The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.
This document is a 510(k) summary for Disposable Sterilized Latex Surgical Gloves, demonstrating substantial equivalence to a predicate device (K171550). It focuses on non-clinical performance data and does not involve AI or clinical studies as typically defined in medical imaging or diagnostic device contexts. Therefore, many of the requested points are not applicable.
Here's an analysis of the provided information in the context of the requested questions:
Acceptance Criteria and Device Performance
This product is a medical device (Disposable Sterilized Latex Surgical Gloves), not an AI algorithm. The "acceptance criteria" and "reported device performance" are based on physical, chemical, and biological properties of the gloves, compared against recognized ASTM and ISO standards.
Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Standard) | Test Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Dimension | |||
| ASTM D3577-09(Reapproved 2015) | Determine length of gloves | 265mm, min | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine width of gloves | Size 6: 76 ±6 mm; Size 6.5: 83 ± 6 mm; Size 7: 89 ± 6 mm; Size 7.5: 95 ± 6 mm; Size 8: 102 ± 6 mm; Size 8.5: 108 ± 6 mm | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine thickness of gloves | Palm: 0.10mm, min; Finger: 0.10mm, min; Cuff: 0.10mm, min | Pass |
| Physical Properties | |||
| ASTM D3577-09(Reapproved 2015) | Determine physical properties (Tensile strength) | Before Ageing Tensile Strength: 24Mpa Minimal for all sizes; After Ageing Tensile Strength: 18Mpa Minimal for all sizes | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine physical properties (Ultimate Elongation) | Before Ageing Ultimate Elongation: 750% Min for all sizes; After Ageing Ultimate Elongation: 560% Min for all sizes | Pass |
| Watertight test | |||
| ASTM D5151-19 | Determine watertightness of gloves | Sample size: 200 pcs; Inspection level: GI; AQL 1.5; Criteria: ≤8 pieces | Pass |
| Residual powder | |||
| ASTM D6124-06 (Reapproved 2017) | Determine residual powder in gloves | 2 mg per glove or less | Pass |
| Protein content | |||
| ASTM D5712 - 15 | Determine extractable protein in gloves | 200 µg/dm² Max for all sizes | Pass |
| Biocompatibility | |||
| ISO 10993-10 | Evaluate potential of a test article to cause skin sensitization | Under the conditions of the study, not a sensitizer | Pass |
| ISO 10993-10 | Evaluate potential skin irritation caused by test article contact with skin surface of rabbits | Under the condition of study, not an irritant | Pass |
| ISO 10993-11:2017 | Evaluate whether leachables extracted from the test article would cause acute systemic toxicity following injection into mice | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Pass |
| USP 43-NF 38 | Evaluate risks of febrile reaction in the rabbit to administration by injection | Under the condition of study, not a pyrogen | Pass |
| USP 43 | Bacterial Endotoxin Test |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).