(71 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
ShieldMaster Powdered Purple Nitrile Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
The provided text describes the acceptance criteria and the study conducted for the ShieldMaster Powdered Purple Nitrile Gloves. As this is a medical device (gloves), the "device" in the context of your request refers to these gloves. The study described is a performance test against established industry standards. There is no AI component or software algorithm involved; therefore, many of the requested fields (e.g., sample size for test set, experts, MRMC study, training set) are not applicable.
Here's the information formatted as requested:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Physical Properties | Meets ASTM D 3578-99 and ASTM D 6319-99 | Meets ASTM D 3578-99 and ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 3578-99 and ASTM D 5151 | Meets ASTM D 3578-99 and ASTM D 5151 |
| Biocompatibility | Primary Skin Irritation in Rabbits: Passes | Passes |
| Biocompatibility | Guinea Pig Sensitization: Passes | Passes |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the performance tests against ASTM standards. The data provenance is internal testing conducted by Safeskin Corporation, presumably in a laboratory setting, to demonstrate compliance with the specified ASTM standards. It is a prospective evaluation as the glove was tested to demonstrate it met the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth is established by objective measurements against predefined ASTM standard specifications, not by expert consensus in this context.
4. Adjudication method for the test set
Not applicable. Testing is against objective ASTM standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., imaging software), not for physical medical devices like gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is established by objective, quantitative measurements against predefined industry standards (ASTM standards) for physical and performance characteristics, and standardized animal testing for biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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.