(143 days)
The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided document is a 510(k) premarket notification for Vinyl Examination Gloves, a Class I medical device. This type of device does not involve AI or complex software, and thus the request asking about AI/algorithm performance metrics is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing, not through AI/algorithm performance.
Therefore, many of the requested points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI models, cannot be extracted from this document as they are not relevant to the device being described.
However, I can extract the acceptance criteria and performance data for the physical properties of the gloves, as well as the non-clinical testing information:
Description of Acceptance Criteria and Study Proving Device Meets Criteria (for Vinyl Examination Gloves)
This document describes the non-clinical testing performed to demonstrate that the Vinyl Examination Gloves (Yellow) are substantially equivalent to a legally marketed predicate device (K163168). The acceptance criteria are based on recognized standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, as well as biocompatibility standards ISO 10993-5 and ISO 10993-10.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (from Standard) | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm): ≥230; | |
| Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5; | |||
| Thickness (mm): Finger: ≥0.08, Palm: ≥0.08 | Length: > 230 / Pass | ||
| Width: S: 84-85/Pass; M: 94-96/Pass; L: 104-106/Pass; XL: 113-115/Pass | |||
| Finger Thickness: 0.12~0.13/Pass | |||
| Palm Thickness: 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.