(169 days)
The Disposable Nitrile 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 Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.
The subject device is non-sterile.
This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: $\ge$ 220; M/L/XL: $\ge$ 230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Length(mm): > 230/Pass; Width(mm): XS: 70-77 /Pass; S: 77-86 /Pass; M: 95-99/ Pass; L: 109-114/ Pass; XL:117-120/ Pass |
| N/A (Section 6) | Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.08-0.11/Pass; Palm: 0.08-0.11/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.3-17.9MPa/Pass; Ultimate Elongation: 496-588%/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 20.0-44.5MPa/Pass; Ultimate Elongation: 450-5710%/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| 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.