(205 days)
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
The provided text is for a 510(k) premarket notification for Nitrile Examination Gloves, a Class I medical device. This type of device is a physical product, not an AI/ML algorithm or software. Therefore, the "acceptance criteria and the study that proves the device meets the acceptance criteria" requested in the prompt refers to physical and biological performance testing for the gloves, not to a study about the performance of an AI model.
Here's the breakdown of the information based on the provided text, adapted for a physical device:
Acceptance Criteria and Device Performance for Nitrile Examination Gloves
The study to prove the device meets acceptance criteria involved non-clinical tests based on recognized standards for medical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Extra-Small: Length: ≥220mm; Width: 70±10 mm | |
| Small: Length: ≥220mm; Width: 80±10mm | |||
| Medium: Length: ≥230mm; Width: 95±10mm | |||
| Large: Length: ≥230mm; Width: 110±10mm | |||
| Extra-Large: Length: ≥230mm; Width: 120±10mm | Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Pass | ||
| ASTM D6319 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa | |
| Ultimate Elongation: ≥500% | Pass | ||
| Physical Properties (After Aging) | Tensile Strength: ≥14MPa | ||
| Ultimate Elongation: ≥500% | Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | 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.