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510(k) Data Aggregation
(37 days)
The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (ASTM D3578-01aE2 or FDA/Internal Requirements) | Reported Device Performance (SGMP / Lot# 4144) |
|---|---|---|
| Dimension | ||
| X-Small Width | 70 mm +/- 10 mm | 70 – 80 mm |
| Small Width | 80 mm +/- 10 mm | 80 – 85 mm |
| Medium Width | 95 mm +/- 10 mm | 90 – 97 mm |
| Large Width | 111 mm +/- 10 mm | 105 - 111 mm |
| Length (all sizes) | 230 mm minimum | 242 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Thickness - Palm | 0.08 mm min | 0.1 mm min |
| Physical Properties | ||
| Ten. Strength Before Aging | 18.0 Mpa | X-Small: 23.5 Mpa; Small: 26.8 Mpa; Medium: 22.5 Mpa; Large: 29.2 Mpa |
| Ult. Elong. Before Aging | 650 % | X-Small: 890 %; Small: 800 %; Medium: 850 %; Large: 870 % |
| Ten. Strength After Aging | 14.0 Mpa | X-Small: 22.8 Mpa; Small: 27.5 Mpa; Medium: 28.3 Mpa; Large: 26.8 Mpa |
| Ult. Elong. After Aging | 500 % | X-Small: 780 %; Small: 820 %; Medium: 750 %; Large: 820 % |
| Water Tight Test | ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL (Acceptance Quality Limit) | Un-aged (X-Small: 0, Small: 1, Medium: 2, Large: 0 leaks); Aged (X-Small: 0, Small: 1, Medium: 1, Large: 2 leaks) - All within 2.5% AQL |
| Biocompatibility | Passed tests for examination gloves (as per APPENDIX K) | Passed (results as per APPENDIX K) |
| Residual Powder Content | FDA Requirement: 2 mg/glove max (ASTM D 6124-00) | Range: 0.4 - 1.0 mg/glove; Mean: 0.8 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level | <50 µg/dm² | <50 µg/dm² (implied by the conclusion and regulatory approval) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Water Tight Test): 125 pieces for each size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 125 * 4 * 2 = 1000 gloves tested for water tightness.
- Sample Size (Physical Properties): Not explicitly stated how many gloves were tested for each physical property (Tensile Strength, Ultimate Elongation) for each size, but the results are reported for each size on "Lot# 4144."
- Data Provenance: The data is retrospective and comes from internal testing conducted by SGMP Company Limited, a company located in Thailand.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable to this type of device (patient examination gloves). The testing involves objective, measurable physical and chemical properties rather than expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements (e.g., dimension, tensile strength, water leak count, chemical analysis).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
Not applicable. This is a medical device (examination glove), not an AI diagnostic or interpretive tool. There are no "human readers" interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-01aE2 (Standard Specification for Latex Examination Gloves for Medical Application) for dimensions and physical properties.
- ASTM D3578-00aE2 (a previous version of the same standard) for physical properties and water-tightness (2.5% AQL).
- FDA specified 1,000 ml water leak test for water tightness.
- ASTM D 6124-00 for Residual Powder Content.
- FDA requirements for powder content and protein labeling claims.
- Biocompatibility test standards (referenced in APPENDIX K).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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