K Number
K211336
Date Cleared
2021-06-16

(44 days)

Product Code
Regulation Number
880.6250
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Disposable Vinyl 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.

Device Description

The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Disposable Vinyl Examination Glove." It details the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device.

Here's the information broken down according to your request:

Acceptance Criteria and Reported Device Performance

Test MethodologyPurposeAcceptance CriteriaReported Device Performance
ASTM D5250Physical Dimensions TestLength (mm): ≥230Length: ≥230/ Pass
Width (mm): XS: 75±5; S: 85±5; M: 95±5; L: 105±5; XL: 115±5XS: 74-77/ Pass
S: 83-87 /Pass
M: 96-97/ Pass
L: 104-108/ Pass
XL: 114-117/ Pass
Thickness (mm): Finger: ≥0.08; Palm: ≥0.08Finger: 0.09-0.14/Pass
Palm: 0.10-0.13/Pass
ASTM D5151Watertightness Test for Detection of HolesMeet the requirements of ASTM D5151 AQL 1.50/125 leaks / Pass
ASTM D6124Powder ContentMeet 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.