(115 days)
The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
This document is a 510(k) summary for Hebei Grandeast Plastic Products Co., Ltd.'s Powder-free PVC Vinyl Exam Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria (Proposed Device) | Reported Device Performance (Proposed Device) | Acceptance Criteria (Predicate Device) | Reported Device Performance (Predicate Device) |
|---|---|---|---|---|
| Dimensions | ||||
| Length | Comply with ASTM D5250-06 (Reapproved 2011): > 230 mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): > 230 mm | Complies |
| Width (S) | Comply with ASTM D5250-06 (Reapproved 2011): 85±5mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): 85±5mm | Complies |
| Width (M) | Comply with ASTM D5250-06 (Reapproved 2011): 95±5mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): 95±5mm | Complies |
| Width (L) | Comply with ASTM D5250-06 (Reapproved 2011): 105±5mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): 105±5mm | Complies |
| Width (XL) | Comply with ASTM D5250-06 (Reapproved 2011): 115±5mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): 115±5mm | Complies |
| Thickness (Palm) | Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): > 0.08mm | Complies |
| Thickness (Finger-tip) | Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mm | Complies | Comply with ASTM D5250-06 (Reapproved 2011): > 0.05mm | Complies |
| Physical Properties | ||||
| Tensile Strength | Before aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011) | Complies | Before aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011) | Complies |
| Ultimate Elongation | Before aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011) | Complies | Before aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011) | Complies |
| Freedom from Holes | Comply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011) | Complies | Comply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011) | Complies |
| Residue Powder | 0.6 +/- 0.1 mg per glove. Comply with ASTM D5250-06 (Reapproved 2011) | Complies |
§ 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.