(18 days)
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination.
Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
Here's a summary of the acceptance criteria and the study for the Shiva Medicare Limited Powder-Free Surgeon's Glove, as derived from the provided document:
This document describes the performance of a medical device, specifically a "Powder free Surgeon's Glove" manufactured by Shiva Medicare Limited, and its adherence to the ASTM D3577 standard. The primary goal of the submission appears to be demonstrating substantial equivalence to a legally marketed predicate device (Class I Surgeon's Glove (Powder free) 79KGO that meets all the requirements of ASTM D3577).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3577 Requirement) | Reported Device Performance (SML Value) | Meets Criteria? |
|---|---|---|---|
| Dimensions | |||
| Length (various sizes) | 245 mm minimum (for 5.5) / 265 mm minimum | 270-272 mm | Yes |
| Width (various sizes) | +/- 6 mm of specified nominal width | 68-112 mm (within tolerance for each size) | Yes |
| Thickness (Cuff) | 0.1 mm minimum | 0.12 mm | Yes |
| Thickness (Palm) | 0.1 mm minimum | 0.16 mm | Yes |
| Thickness (Fingertip) | 0.1 mm minimum | 0.19 mm | Yes |
| Physical Properties (Before Ageing) | |||
| Tensile Strength | 24 mpa | 27 mpa | Yes (Exceeds) |
| Elongation at break % | 750% | 850% | Yes (Exceeds) |
| Modulus at 500% elongation | 5.5 mpa (max) | 3 mpa | Yes (Below max) |
| Physical Properties (After Ageing) | |||
| Tensile Strength | 18 mpa min | 20 mpa | Yes (Exceeds) |
| Elongation at break % | 560% min | 750% | Yes (Exceeds) |
| Performance Requirements | |||
| Sterility | As per USP* | As per IP* (Indian Pharmacopea) | Yes (Equivalent standard used) |
| Freedom from Holes | S4 (AQL 1.5) | S4 (AQL 1.5) | Yes |
| Dimension | S2 (AQL 4) | S2 (AQL 4) | Yes |
| Physical Property | S2 (AQL 4) | S2 (AQL 4) | Yes |
| Powder Content | Not explicitly stated in D3577 |
§ 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).