(388 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM IN-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LtZ, and meets all requirement of ASTM Standard D5250-06 (2011).
This 510(k) submission is for Powder-Free Vinyl Patient Examination Gloves, which are Class I devices that typically do not require clinical studies. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM standards. Therefore, many of the typical AI/software-based study questions are not applicable.
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Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to ASTM-D-5250-06 (2011) | Full conformity to ASTM-D-5250-06 (2011) standard |
| Meets FDA pinhole requirements | Meets pinhole FDA requirements |
| Meets biocompatibility requirements | Meets biocompatibility requirements (Primary Skin irritation and Skin Sensitization testing showed no adverse reactions) |
| Meets labeling claims | Meets labeling claims |
| Powder-free (residual powder |
§ 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.