(31 days)
The 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.
The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.
Here's a breakdown of the acceptance criteria and study information for the "Dermagrip Powder Free Latex Examination Gloves" based on the provided 510(k) summary:
This device is a medical glove, and the studies performed are for validating performance characteristics against established ASTM (American Society for Testing and Materials) and FDA standards, not for evaluating an AI algorithm's diagnostic performance. Therefore, many of the requested categories related to AI studies (e.g., sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable to this type of device and study.
Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 – 01EI | Meets |
| Physical Properties | ASTM D 3578 – 01EI | Meets |
| Freedom from pinholes | ASTM D 3578 – 01EI FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 – 01 |
§ 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.