(109 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for Synthetic Nitrile Examination Gloves. It details the device's characteristics, its intended use, and comparative testing against a predicate device to establish substantial equivalence.
Based on the document, I can provide the acceptance criteria and study details for the device as follows:
Acceptance Criteria and Device Performance
The acceptance criteria for the Synthetic Nitrile Examination Gloves are primarily based on performance standards and biocompatibility. The reported device performance is compared against these criteria.
Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test - Length | $\ge$ 230 mm | > 240 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Width (S) | 85 ± 5 mm | 87-88 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Width (M) | 95 ± 5 mm | 96-98 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Width (L) | 105 ± 5 mm | 105-107 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Width (XL) | 115 ± 5 mm | 116 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Thickness (Finger) | $\ge$ 0.08 mm | 0.12-0.13 mm | Pass |
| ASTM D5250 | Physical Dimensions Test - Thickness (Palm) | $\ge$ 0.08 mm | 0.08-0.09 mm | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 (implies 0 defects in 125 samples, meeting AQL 2.5 criteria) | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 ($ |
§ 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.