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510(k) Data Aggregation
(34 days)
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.
The provided document does not describe an AI medical device. It pertains to a Non-Sterile Powder-Free Green Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a Protein Labeling Claim (<50uG/G).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and AI performance metrics is not applicable in the context of an AI device.
However, I can extract the acceptance criteria and performance of the latex examination gloves as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance for Latex Examination Gloves
| Test | Acceptance Criteria (ASTM D3578-01aE2 or FDA) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension | ||
| Width | ||
| X-Small | 70 mm +/- 10 mm | 70 - 75 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 |
| Length | 230 mm minimum for all sizes | 242 mm |
| Thickness | ||
| Finger | 0.08 mm min | 0.08 mm min |
| Palm | 0.08 mm min | 0.08 mm min |
| Physical Properties (Tensile Strength) | ||
| Before Aging | 14.0 Mpa | X-Small: 26.0 MpaSmall: 27.3 MpaMedium: 27.9 MpaLarge: 27.4 Mpa |
| After Aging | 14.0 Mpa | X-Small: 24.5 MpaSmall: 28.5 MpaMedium: 28.0 MpaLarge: 21.5 Mpa |
| Physical Properties (Ultimate Elongation) | ||
| Before Aging | 700 % | X-Small: 990 %Small: 880 %Medium: 860 %Large: 870 % |
| After Aging | 500 % | X-Small: 950 %Small: 950 %Medium: 950 %Large: 920 % |
| Water Tight Test (Leak Status) | 2.5% AQL (acceptable quality level) for leaks (implied by meeting ASTM D3578-01aE2) | Un-aged: X-Small: 1 leak (0.8%)Small: 0 leaks (0%)Medium: 0 leaks (0%)Large: 1 leak (0.8%)Aged: X-Small: 0 leaks (0%)Small: 0 leaks (0%)Medium: 1 leak (0.8%)Large: 1 leak (0.8%)All reported leaks are within 2.5% AQL. |
| Residual Powder Content | 2 mg/glove max | Range: 0.5-0.8 mg/gloveMean: 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level (ASTM D 5712-99) | < 50 µg/g | < 50 µg/g |
| Biocompatibility | Gloved passed tests for examination gloves (as per APPENDIX L) | Passed |
Regarding the other points, as this is not an AI device, the following are not applicable:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For the physical and watertight tests, the "test set" consisted of various glove sizes from Lot# 0320.
- Dimensions, Physical Properties, Residual Powder Content, Presence of Cornstarch, Residual Protein Level: Data is reported for Lot# 0320. The sample sizes are not explicitly stated for all tests, but for the watertight test, 125 pieces of each size were tested for both un-aged and aged conditions. The data provenance is not specified, but it implies internal testing by SGMP Company Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water leak test) not by expert consensus in a medical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device. Performance is determined by objective measurements against established standards.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the glove performance is based on established engineering and medical device standards (e.g., ASTM D3578-01aE2, FDA water leak test, ASTM D 6124-01, ASTM D 5712-99) and objective measurements.
8. The sample size for the training set:
Not applicable. This is not an AI device, and thus does not have a "training set."
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
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