(99 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 synthetic patient examination gloves. The subject device is blue. 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 text is a 510(k) Summary for a medical device, "Disposable Vinyl Nitrile Synthetic Gloves Powder Free" (K211516). This document details the device's characteristics and its equivalence to a predicate device, as submitted to the FDA.
Based on the nature of the device (disposable patient examination gloves) and the content of the summary, the "device" in question is not an AI/ML-driven diagnostic or assistive technology. Instead, it is a physical medical device. Therefore, the questions related to AI/ML device performance metrics (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size, etc.) are not applicable to this document.
The acceptance criteria and performance are related to the physical properties, safety, and regulatory compliance of the gloves.
Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and how it meets them:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D5250 | Physical Dimensions | Length: ≥230 mm | ||
| Width (S): 85±5 mm | ||||
| Width (M): 95±5 mm | ||||
| Width (L): 105±5 mm | ||||
| Width (XL): 115±5 mm | ||||
| Thickness (Finger): ≥0.08 mm | ||||
| Thickness (Palm): ≥0.08 mm | Length: >230 mm | |||
| Width (S): 88-90 mm | ||||
| Width (M): 95-97 mm | ||||
| Width (L): 106-108 mm | ||||
| Width (XL): 113-116 mm | ||||
| Finger Thickness: 0.08-0.10 mm | ||||
| Palm Thickness: 0.09 mm | Pass | |||
| ASTM D5151 | Watertightness | 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.