(60 days)
The Nitrile Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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.
The provided document is a 510(k) Premarket Notification for a Nitrile Glove, which is a Class I medical device. Therefore, the "device" in this context is a physical product (a medical glove), not a software or AI-driven diagnostic tool. The questions you've asked are highly relevant to the evaluation of AI/ML-based medical devices, specifically regarding their performance on test sets, ground truth establishment, and clinical studies.
Since the document describes a physical medical device (nitrile glove) and not an AI or software device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context relate to physical properties, performance standards, and biocompatibility rather than diagnostic accuracy, reader studies, or training sets for AI models.
Therefore, I cannot extract the information requested in your prompt because it pertains to a different type of medical device (AI/ML) than what is described in the provided text.
However, I can extract the acceptance criteria and performance data relevant to this specific device (Nitrile Glove) as described in the document.
Acceptance Criteria and Device Performance for a Nitrile Glove
The document details performance testing for the Nitrile Glove based on established ASTM and ISO standards for examination gloves.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): |
- S: ≥220
- M/L/XL: ≥230
Width (mm): - S: 80±10
- M: 95±10
- L: 110±10
- XL: 120±10
Thickness (mm): - Finger: ≥0.05
- Palm: ≥0.05 | Length:
- S: >220/Pass
- M/L/XL: >230/Pass
Width: - S: 81-85 /Pass
- M: 91-96/ Pass
- L: 102-106/ Pass
- XL: 114-116/Pass
Thickness: - Finger: 0.06-0.08/Pass
- Palm: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 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.