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510(k) Data Aggregation
(146 days)
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
This document is a 510(k) summary for a Sterile Latex Surgeon's Glove (Powder Free). It focuses on demonstrating substantial equivalence to a predicate device by meeting ASTM D3577 and FDA requirements.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 / FDA Requirement) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Dimensions | |||
| Length (5 ½ - 9) | 245 mm minimum (for 5 ½), 265 mm minimum (for 6-9) | 270-272 mm (all sizes) | Yes |
| Width (5 ½) | 70 +/- 6 mm | 68 mm | Yes |
| Width (6) | 76 +/- 6 mm | 73 mm | Yes |
| Width (6 ½) | 83 +/- 6 mm | 79 mm | Yes |
| Width (7) | 99 +/- 6 mm | 87 mm | Yes |
| Width (7 ½) | 95 +/- 6 mm | 92 mm | Yes |
| Width (8) | 105 +/- 6 mm | 103 mm | Yes |
| Width (8 ½) | 108 +/- 6 mm | 106 mm | Yes |
| Width (9) | 114 +/- 6 mm | 112 mm | Yes |
| Thickness | 0.1 mm minimum (cuff, palm, fingertip) | 0.12, 0.16, 0.19 mm (cuff, palm, fingertip) | Yes |
| Physical Properties (Before Ageing) | |||
| Tensile Strength | 24 mpa | 27 mpa | Yes |
| Elongation at break % | 750% | 850% | Yes |
| Modulus at 500% elongation | 5.5 mpa (max) | 3 mpa | Yes |
| Physical Properties (After Ageing) | |||
| Tensile Strength | 18 mpa min | 20 mpa | Yes |
| Elongation at break % | 560% min | 750% | Yes |
| Performance Requirements | |||
| Sterility | As per USP* | As per IP* | Yes (equivalent standard) |
| Freedom from Holes | 1.5 AQL (S4) | 1.5 AQL (S4) | Yes |
| Dimension | 4 AQL (S2) | 4 AQL (S2) | Yes |
| Physical Property | 4 AQL (S2) | 4 AQL (S2) | Yes |
| Additional Properties | |||
| Powder Content | 2 mg/glove max | Nil Powder (1 +/- 1 mg/glove) | Yes |
| Protein Content | 200 ppm max | 80 +/- 20 ppm | Yes |
| Moisture Content | N/A (implied by "value fixed", "0.8% max") | 0.8% max | Yes |
| Biocompatibility | Biologically Compatible | Biologically Compatible | Yes |
Note: IP (Indian Pharmacopeia) is considered equivalent to USP (United States Pharmacopeia) for sterility in this context.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for length, width, tensile strength, etc.). However, it refers to general AQL (Acceptance Quality Limit) levels (S2 and S4) for performance requirements like freedom from holes, dimensions, and physical properties. These AQL levels imply a sampling plan, but the exact number of units sampled is not provided.
The data provenance is for gloves manufactured by Brightway Gloves Pvt. Ltd. in Tamil Nadu, India. This is retrospective data, as it describes the performance of already manufactured gloves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not involve a test set requiring expert ground truth establishment in the traditional sense (e.g., image interpretation). Instead, the "ground truth" for compliance testing is established by recognized standards: ASTM D3577 (Standard Specification for Rubber Surgical Gloves) and FDA requirements/USP/IP standards. Therefore, no specific number of human experts for ground truth is applicable here. The experts involved are those who developed and maintain these national and international standards.
4. Adjudication Method for the Test Set
Not applicable. The evaluation is based on direct measurement and comparison against defined standard specifications, not on subjective expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a performance specification and substantial equivalence study for a medical device (surgical gloves), not an AI algorithm requiring MRMC studies.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This study is about the physical and chemical properties of a medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is established industry and regulatory standards:
- ASTM D3577 requirements for latex surgeon's gloves.
- FDA requirements for attributes like pinholes and protein content.
- USP (United States Pharmacopeia) or IP (Indian Pharmacopeia) for sterility.
8. Sample Size for the Training Set
Not applicable. This device is manufactured using a process, and its performance is evaluated against specifications, not "trained" in the way an AI model is trained.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device. The manufacturing process is designed to meet the established standards and is subject to quality control to ensure consistency.
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