(141 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. lt can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This document is a 510(k) Premarket Notification for NBR Synthetic Examination Gloves, indicating that it is a Class I medical device (non-powdered patient examination glove). The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove de novo a device's safety and effectiveness through extensive clinical trials for new technologies.
As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing and biocompatibility assessments performed to demonstrate that the new device meets established standards for patient examination gloves and is substantially equivalent to a predicate device. There is no AI or diagnostic component to this device, so many of the common questions related to AI/ML device studies (e.g., ground truth, MRMC studies, training sizes) are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards for medical gloves (e.g., ASTM, ISO). The reported device performance indicates compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D5250: Physical Dimensions Test | ||||
| Length (mm) | Length | $\ge$ 230 | > 240 | Pass |
| Width (mm) | Width | S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | S: 86-89; M: 95-97; L: 106-108; XL: 115-117 | Pass |
| Thickness (mm) | Thickness | Finger: $\ge$ 0.08; Palm: $\ge$ 0.08 | Finger: 0.08-0.16; Palm: 0.08-0.13 | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 | Pass |
| ASTM D6124 | Residual 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.