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510(k) Data Aggregation
(207 days)
The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (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 meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
This document describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (50 Micrograms or Less)" submitted by SGMP Company Limited.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578-05 Standard / FDA Requirement) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension (Width) | X-Small: 70 mm +/- 10 mm | 70 – 80 mm |
| Small: 80 mm +/- 10 mm | 80 – 85 mm | |
| Medium: 95 mm +/- 10 mm | 90 – 97 mm | |
| Large: 111 mm +/- 10 mm | 105 - 111 mm | |
| Dimension (Length) | 230 mm minimum (for all sizes) | 240 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Thickness - Palm | 0.08 mm min | 0.10 mm min |
| Tensile Strength (Before Aging) | 18.0 Mpa | X-Small: 25.1 MpaSmall: 22.8 MpaMedium: 28.0 MpaLarge: 26.3 Mpa |
| Tensile Strength (After Aging) | 14.0 Mpa | X-Small: 24.5 MpaSmall: 23.5 MpaMedium: 26.0 MpaLarge: 25.2 Mpa |
| Ultimate Elongation (Before Aging) | 650 % | X-Small: 830 %Small: 870 %Medium: 850 %Large: 855 % |
| Ultimate Elongation (After Aging) | 500 % | X-Small: 790 %Small: 805 %Medium: 780 %Large: 770 % |
| Water Tight Test (AQL) | 2.5% AQL (ASTM D3578-05 requirements) | Un-aged (Batch #7023):X-Small: 0 leaked (0%)Small: 2 leaked (1.6%)Medium: 1 leaked (0.8%)Large: 1 leaked (0.8%)Aged (Batch #7023):X-Small: 2 leaked (1.6%)Small: 0 leaked (0%)Medium: 1 leaked (0.8%)Large: 0 leaked (0%)All reported values are ≤ 2.5% |
| Biocompatibility | Passed tests for examination gloves (as per APPENDIX K) | Passed |
| Residual Powder Content | 10 mg/glove max (ASTM D 6124-06) | Ranger: 0.8-1.7 mg/gloveMean: 1.4 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level | < 50 µg/dm2 (ASTM D 5712-99) | < 50 µg/dm2 |
2. Sample Size for Test Set and Data Provenance
- Dimension, Physical Properties, Residual Powder Content, Presence of Cornstarch, Residual Protein Level: The sample sizes for these tests are not explicitly stated for individual characteristics beyond the Water Tight Test. Data is reported for Lot #7023.
- Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested, both un-aged and aged. This totals 1000 gloves (125 gloves x 4 sizes x 2 aging conditions).
- Data Provenance: The document states "Internal SGMP'S" for the residual powder content, indicating the data was generated internally by the manufacturer. The country of origin of the manufacturer is Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand). The data appears to be prospective testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical product (latex examination gloves), and its performance is evaluated against established physical, mechanical, and chemical standards (e.g., ASTM standards, FDA requirements) rather than subjective expert interpretation of data like medical images.
4. Adjudication Method for the Test Set
Not applicable. Performance is measured against objective standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or a device involving human interpretation of outputs. Therefore, an MRMC study is irrelevant.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies of the device (the examination gloves) against defined standards and criteria, without human-in-the-loop performance being a factor for its primary function.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements. Specifically:
- ASTM D3578-05 Standard Specification for Latex Examination Gloves for Medical Application for dimensions, physical properties (tensile strength, ultimate elongation), and water tight test AQL.
- FDA specified 1,000 ml water leak test procedure.
- ASTM D 6124-06 for Residual Powder Content.
- ASTM D 5712-99 for Residual Protein Level.
- General biocompatibility tests for examination gloves (details in Appendix K, not provided).
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI algorithms that require a "training set." The product is a manufactured good tested against specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant for this device.
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