(73 days)
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nitrile Powder Free Patient Examination Gloves.
It's important to note that this document is a 510(k) summary for a Class I medical device (gloves). For such devices, clinical studies are typically not required, and the focus is on meeting established performance standards (ASTM, FDA regulations). Therefore, many of the typical AI/software device evaluation criteria (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not applicable or present in this submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Standard | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6139-05 | Meets |
| Physical Properties | ASTM standard D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets (Waterleak test on pinhole AQL) |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 |
§ 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.