(173 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-Free Clear Vinyl Patient Examination Gloves (K142892).
It's important to note that this document is a 510(k) summary for a Class I medical device (patient examination glove). For such devices, the FDA typically relies on performance standards and substantial equivalence to a predicate device rather than extensive clinical trials for approval.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM Standards/Biocompatibility) | Reported Device Performance (K142892) |
|---|---|
| Physical Properties (ASTM D5250-06) | |
| Length on Large Size | Conform to ASTM D5250, 2011 |
| Width of Palm on Large Size | Conform to ASTM D5250, 2011 |
| Palm Thickness | Conform to ASTM D5250, 2011 |
| Fingertip Thickness | Conform to ASTM D5250, 2011 |
| Before & After Aging: Tensile Strength (Mpa) | ≥11MPa (Tensile strength) (Conform to ASTM D5250-06) |
| Before & After Aging: Ultimate Elongations | ≥360% (elongation) (Conform to ASTM D5250-06) |
| Barrier Properties (ASTM D5151-06) | |
| Pinhole Results | AQL 2.5 (Conform to ASTM D5151-06) |
| Residual Powder (ASTM D6124) | |
| 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.