(17 days)
Disposable Vinyl Examination Gloves 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.
The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":
This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.
Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS | Acceptance Criteria | DEVICE PERFORMANCE (Reported) |
|---|---|---|---|
| Dimensions | ASTM D5250-19 | Pass | |
| Length | 230 mm min | 240 mm min | |
| Width (S) | $85\pm5$ mm | 89-90 mm | |
| Width (M) | $95\pm5$ mm | 99 mm | |
| Width (L) | $105\pm5$ mm | 105-106 mm | |
| Width (XL) | $115\pm5$ mm | 119-120 mm | |
| Thickness (Palm) | Min 0.08 mm | 0.080 mm Min | |
| Thickness (Finger) | Min 0.08 mm | 0.080 mm Min | |
| Physical Properties | ASTM D5250-19 | Pass | |
| Before Aging: | |||
| Tensile Strength | 11 MPa, min. | 16.0 MPa, min. | |
| Elongation | 300%, min. | 304%, min. | |
| After Aging: | |||
| Tensile Strength | 11 MPa, min. | 16.7 MPa, min. | |
| Elongation | 300%, min. | 301%, min. | |
| Freedom from holes | ASTM D5250-19, | No leakage at sampling level of | Pass |
| ASTM D5151-19 | G-1, AQL 2.5 | No leakage, 80 of 80 passed | |
| Residual Powder | ASTM D6124-06 |
§ 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.