(144 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)
The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results for 3 Lots) | Outcome |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | XS/S: ≥220 mm; M/L/XL: ≥230 mm | Lot1, Lot2, Lot3: >230 mm | Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Lot1: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | |
| Lot2: XS: 79-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | ||||
| Lot3: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | Pass | |||
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Lot1: Finger: 0.11-0.13, Palm: 0.06-0.07 | |
| Lot2: Finger: 0.11-0.13, Palm: 0.06-0.07 | ||||
| Lot3: Finger: 0.11-0.13, Palm: 0.07 | Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Lot1: 0/125 leaks | |
| Lot2: 0/125 leaks | ||||
| Lot3: 0/125 leaks | 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.