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510(k) Data Aggregation
(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 | < 2 mg/glove max (Implicit from "Powder free") | Yes |
| Protein Content | Not explicitly stated in D3577 | 80 +/- 20 ppm | Yes |
| Moisture Content | Not explicitly stated in D3577 | 0.8% max | Yes |
| Biocompatibility | Biologically Compatible | Biologically Compatible | Yes |
*Note on Sterility: While the ASTM D3577 requirement for sterility is "As per USP", Shiva Medicare Limited states "As per IP (Indian Pharmacopea)". The submission would need to demonstrate that the Indian Pharmacopea standard is equivalent to or more stringent than USP for this characteristic. The FDA's acceptance of the 510(k) suggests this was deemed acceptable.
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the specific number of gloves used for each test (e.g., number of gloves for length, width, tensile strength, or freedom from holes). However, AQL (Acceptable Quality Level) levels like S2 and S4 are mentioned, which imply a statistical sampling plan was used according to ISO 2859-1 (likely MIL-STD-105E or its commercial equivalents like ASTM D3577 Appendix X2 and X3). The AQLs (1.5 for holes, 4 for dimensions and physical properties) indicate the acceptable batch quality.
- Data Provenance: The data is reported by Shiva Medicare Limited, an Indian manufacturer. The context (510(k) submission to FDA) indicates this data was generated to support market clearance in the USA. The data is retrospective, as it's being presented for a device that has already undergone testing for market application.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is a surgical glove, and its performance is evaluated against objective, measurable physical and chemical properties defined by a recognized standard (ASTM D3577). The ground truth is the scientific measurement of these properties, not subjective expert opinion.
4. Adjudication Method for the Test Set:
Not applicable. Evaluation relies on objective measurements against a standard, not expert consensus. Quality control aspects like "Freedom from Holes," "Dimension," and "Physical Property" follow AQL (Acceptable Quality Level) methods, which involve statistically sampling batches and passing/failing based on the number of defects found. This is a statistical process, not an adjudication process by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a surgical glove, not an AI-assisted diagnostic tool or an imaging device that involves human readers or interpretation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical product (surgical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties.
7. Type of Ground Truth Used:
The ground truth used is primarily objective physical and chemical measurements compared against established industry standards (ASTM D3577) and regulatory requirements (e.g., sterility per Indian Pharmacopea/USP, biocompatibility per FDA requirements).
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a physical surgical glove. The "ground truth" for ensuring the glove's quality is established through adherence to manufacturing processes and quality control testing that aims to meet the specified standards.
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