(228 days)
Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.
Latex Patient Examination Gloves, LYY, Powdered
1. A table of acceptance criteria and the reported device performance
| TEST | REQUIREMENT | IN-HOUSE QUALITY PERFORMANCE |
|---|---|---|
| 1. Water Leak Test (1000ml) | GII, AQL 2.5 | Pass GI, AQL 1.5 |
| 2. Length (mm) | ||
| Size: XS | Min. 220 | Minimum 290 mm for all sizes |
| S | Min. 230 | Minimum 290 mm for all sizes |
| M | Min 230 | Minimum 290 mm for all sizes |
| L | Min 230 | Minimum 290 mm for all sizes |
| XL | - | Minimum 290 mm for all sizes |
| 3 Palm Width (mm) | ||
| Size : XS | $70\pm10$ | 75-78 |
| S | $80\pm10$ | 82-86 |
| M | $90\pm10$ | 92-95 |
| L | $100\pm10$ | 103-109 |
| XL | - | 111-115 |
| 4. Thickness (mm) (Single layer) | ||
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical Properties | ||
| Before Ageing | ||
| Tensile Strength (MPa) | Min. 14 | Min 18 |
| Ultimate Elongation (%) | Min 700 | Min 700 |
| After Ageing | ||
| Tensile Strength (MPa) | Min.14 | Min. 14 |
| Ultimate Elongation (%) | 500 | 500 |
| 6. Powder Content | ASTM 6124 | Below 10.0 mg/glove |
| 7. Protein Content | ASTM 5712 | Below 200 µg/dm² |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The data provenance and sample size for the test set are not specified in the provided text.
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. The study is about the quality performance of examination gloves, not an AI diagnostic device requiring expert interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The study is about the quality performance of examination gloves, not an AI diagnostic device requiring 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 not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the gloves is based on industry standards and regulatory requirements, specifically:
- ASTM D 3578-01 Standard
- FDA's pinhole requirement
- FDA's minimum powder residual content
- CMDR requirement
- CGSB requirement
- Label Claim of 200 µg/dm² or less of total water extractable protein content (based on ASTM 5712)
- Biocompatibility Test (Primary Dermal Irritation Study and Dermal Sensitization Study).
8. The sample size for the training set
Not applicable. The provided document concerns the physical and chemical properties of examination gloves, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The provided document concerns the physical and chemical properties of examination gloves, not an AI model.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.