(149 days)
The Nitrile Patient 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.
The provided text is a 510(k) Premarket Notification from the FDA for Nitrile Patient Examination Gloves. It details the device's characteristics and its comparison to a predicate device, focusing on physical properties, safety, and compliance with established standards.
The request asks for information regarding acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device, including aspects like sample sizes, expert involvement, ground truth, and MRMC studies.
However, the provided document DOES NOT describe an AI/ML-driven device. It describes a physical medical device: Nitrile Patient Examination Gloves. Therefore, much of the requested information (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance, AI assistance effect size) is not applicable to this document.
I will focus on the applicable aspects of the request based on the provided document.
Acceptance Criteria and Study for Nitrile Patient Examination Glove
The study described is a non-clinical performance and safety testing of the Nitrile Patient Examination Glove to demonstrate its substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a detailed table in Section 8.0, "Discussion of Non-clinical and Performance Testing," outlining the acceptance criteria and results.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230. | |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10. | |||
| Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length (mm): >230 (Pass) | ||
| Width (mm): XS: 77-79, S: 81-84, M: 88-91, L: 103-107, XL: 111-115 (Pass) | |||
| Thickness (mm): Finger: 0.08-0.09, Palm: 0.08-0.09 (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.