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510(k) Data Aggregation
(213 days)
The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 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 meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and the study conducted for "Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less)."
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (ASTM D3578-05) | Reported Device Performance (SGMP) | Pass/Fail |
|---|---|---|---|
| Dimension | |||
| X-Small (Width) | 70 mm +/- 10 mm | 70 - 80 mm | Pass |
| Small (Width) | 80 mm +/- 10 mm | 80 - 85 mm | Pass |
| Medium (Width) | 95 mm +/- 10 mm | 90 - 97 mm | Pass |
| Large (Width) | 111 mm +/- 10 mm | 105 - 111 mm | Pass |
| Length (all sizes) | 230 mm minimum | 240 mm | Pass |
| Thickness - Finger | 0.08 mm min | 0.13 mm min | Pass |
| Thickness - Palm | 0.08 mm min | 0.10 mm min | Pass |
| Physical Properties | |||
| Tensile Strength (Mpa) | |||
| Before Aging | 18.0 Mpa | X-Small: 23.5 MpaSmall: 28.8 MpaMedium: 22.7 MpaLarge: 25.5 Mpa | Pass |
| After Aging | 14.0 Mpa | X-Small: 21.8 MpaSmall: 25.5 MpaMedium: 22.3 MpaLarge: 23.8 Mpa | Pass |
| Ultimate Elongation (%) | |||
| Before Aging | 650 % | X-Small: 780 %Small: 920 %Medium: 835 %Large: 810 % | Pass |
| After Aging | 500 % | X-Small: 740 %Small: 850 %Medium: 780 %Large: 830 % | Pass |
| Water Tight Test | 2.5% AQL (max. 25 leaky gloves per 1000) | UN-AGED: 2-2-1-2 leaky gloves (total 7/500)AGED: 0-3-2-1 leaky gloves (total 6/500) | Pass |
| Total Residual Powder Content | 10 mg/dm² max (ASTM D 6124-06) | Range: 5.2 - 8.5 mg/dm²Mean: 7.5 mg/dm² | Pass |
| Residual Protein Level | < 200 µg/dm² (ASTM D 5712-99) | < 200 µg/dm² | Pass |
| Biocompatibility | General requirements for examination gloves | Passed tests (as per Appendix H) | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Water Tight Test: 125 pieces for each glove size (X-Small, Small, Medium, Large) for both un-aged and aged conditions. This totals 1000 gloves tested (125 * 4 sizes * 2 conditions).
- Sample Size for Physical Properties: Not explicitly stated but implied to be sufficient for testing tensile strength and ultimate elongation for each size, both before and after aging.
- Sample Size for Total Residual Powder Content: Not explicitly stated, but a range and mean are provided, suggesting multiple measurements.
- Sample Size for Residual Protein Level: Not explicitly stated, but the "Claimed Level" implies testing was performed.
- Data Provenance: The report is submitted by SGMP Company Limited, located in Thailand. The testing standards (ASTM) are international. The data is retrospective, as it's presented as the results of completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by objective, standardized laboratory tests according to ASTM (American Society for Testing and Materials) standards, such as D3578-05 for latex examination gloves, D6124-06 for residual powder, and D5712-99 for protein level. There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. Physical and chemical properties of gloves are measured using standardized test methods, not through expert adjudication.
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 submission for a medical device (examination gloves), not an artificial intelligence (AI) diagnostic or assistive technology. Therefore, no MRMC or AI-related effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating the gloves' performance is based on objective, standardized test methods and specifications outlined in:
- ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application (for dimensions, physical properties, and water-tightness AQL).
- ASTM D 6124-06 for Total Residual Powder Content.
- ASTM D 5712-99 for Residual Protein Level.
- Biocompatibility tests (details in Appendix H, not provided, but implying standard in vitro/in vivo biocompatibility assessments).
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI component requiring a "training set" for this medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
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