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510(k) Data Aggregation
(97 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm): $\ge$ 230;Width(mm):XS: 75 $\pm$ 5;S: 85 $\pm$ 5;M: 95 $\pm$ 5;L: 105 $\pm$ 5;XL: 115 $\pm$ 5;Thickness (mm):Finger: $\ge$ 0.08Palm: $\ge$ 0.08 | Length: >230/ PassWidth:XS: 78-80/ PassS: 85-86/PassM: 95-96/PassL: 105-106/PassXL: 115-116/PassFinger Thickness:XS: 0.11-0.12/PassS:0.11-0.12/PassM:0.11-0.13/PassL:0.11-0.13/PassXL:0.11-0.13/PassPalm Thickness:XS:0.08-0.09/PassS:0.08-0.09/PassM:0.08-0.09/PassL:0.08-0.09/PassXL:0.08-0.09/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | XS:0/125;S:1/125;M:3/125; L:2/125;XL:2/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.89 mg/Pass; S: 0.92 mg/Pass; M: 0.91 mg/Pass; L: 0.92 mg/Pass; XL: 0.95 mg/Pass; |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
2. Sample size used for the test set and the data provenance
- ASTM D5151 (Watertightness): For detection of holes, the sample size was 125 gloves per size (XS, S, M, L, XL), with results like "XS:0/125; S:1/125; M:3/125; L:2/125; XL:2/125 leaks".
- ASTM D6124 (Powder Content): The sample size appears to be one glove per size for the reported powder content (e.g., "XS:0.89 mg/Pass").
- For other tests (ASTM D5250 Physical Dimensions, ASTM D412 Physical Properties, ISO 10993-5 Cytotoxicity, ISO 10993-10 Irritation and Sensitization), specific sample sizes are not detailed in the provided summary.
- Data Provenance: The document does not explicitly state the country of origin for the test data or whether it was retrospective or prospective. Given the submitter's address in China, it is likely the testing was conducted there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML powered device, and the tests relate to physical and biological properties, not interpretation by experts.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against defined standards, not requiring adjudication by experts.
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/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on established industry standards and regulatory requirements (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). The "ground truth" is adherence to these specifications as measured by laboratory testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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