(56 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
Conform® No Powder (Protein Labeling Claim) examination gloves are a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
The provided text describes the acceptance criteria and performance of "Conform® No Powder (Protein Labeling Claim)" examination gloves, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Freedom from holes | Meets ASTM D 3578; Meets ASTM D 5151 | Meets ASTM D 3578; Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass; Meets described test in Attachment VI | Not more than 2 mg residue by mass; Meets described test in Attachment VI |
| Protein Label Claim | This latex glove contains 50 micrograms or less of total water extractable protein per gram. | This latex glove contains 50 micrograms or less of total water extractable protein per gram. |
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Hypoallergenic/Modified Draize | Passes in 200 human subjects | Passes in 200 human subjects |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For the Hypoallergenic/Modified Draize test, 200 human subjects were used.
- For other tests (Dimensions, Physical Properties, Freedom from holes, Powder-Free, Protein Label Claim, Primary Skin Irritation, Guinea Pig Sensitization), the sample sizes are not explicitly stated, but are implied to be sufficient for meeting the respective ASTM standards and internal tests.
- Data Provenance: Not explicitly stated, but the testing was conducted by Ansell Perry Inc. as part of their 510(k) submission to the FDA in the USA. It is implied to be prospective testing for the purpose of regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes performance testing for a medical device (examination gloves) against established standards (ASTM) and biocompatibility tests. It does not involve "ground truth" derived from expert consensus in the same way an AI diagnostic device would.
- The "ground truth" is defined by the objective measurements and pass/fail criteria of the specified ASTM standards and biocompatibility tests.
- Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not directly applicable in the context of this device's evaluation. The experts would be the accredited laboratories and personnel performing the standardized tests.
4. Adjudication method for the test set:
- Not applicable in the traditional sense for an AI system. The device's performance is adjudicated by its adherence to the quantitative and qualitative requirements of the ASTM standards and biocompatibility tests.
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:
- No. This is not an AI diagnostic device, but rather a physical medical device (examination glove). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI system. The performance evaluated is the standalone performance of the physical glove itself based on material properties and biological interaction.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on objective measurement against established industry standards (ASTM D 3578, ASTM D 5151), chemical analysis (for powder residue and protein content), and biological test outcomes (Primary Skin Irritation, Guinea Pig Sensitization, Hypoallergenic on human subjects).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device evaluation.
§ 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.