(126 days)
The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s)to prevent contamination between patient and examiner.
Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Nitrile Examination Gloves (Blue) with Natural Water Soluble Vitamin E and Aloe Vera, Peppermint Scented."
It's important to note that this device is a Class I medical device (patient examination glove), which typically undergoes different and less stringent testing than more complex AI-powered diagnostic devices. Therefore, many of the requested categories (like MRMC studies, expert consensus on ground truth, or sample sizes for test/training sets in the context of an AI algorithm) are not applicable here.
Acceptance Criteria and Device Performance
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00ae3 | Meets |
| Physical Properties | ASTM D 6319-00ae3 | Meets |
| Freedom from Pinholes | ASTM D 6319-00ae3, FDA 21 CFR 800.20 | Meets |
| Powder Residue | ASTM D 6124-01 | Meets, |
§ 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.