(88 days)
The disposable medical nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This is a 510(k) summary for Disposable Medical Nitrile Examination Gloves. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI-powered device, human readers, or a ground truth established by experts. Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of the information that can be extracted or noted as not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length: S: ≥220mm; M/L/XL: ≥230mm; Width: S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; Thickness: Finger: ≥0.05mm; Palm: ≥0.05mm | Length: > 240mm (Pass); Width: S: 84-88mm (Pass); M: 96-98mm (Pass); L: 106-108mm (Pass); XL: 110-113mm (Pass); Thickness: Finger: 0.11-0.13mm (Pass); Palm: 0.07-0.08mm (Pass) |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 holes found in 125 samples, meeting AQL 2.5) |
| 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.