K Number
K122396
Date Cleared
2013-01-31

(177 days)

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

The powdered vinyl patient examination glove, clear (non-colored) 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 powder is made from cornstarch. It is color free and is sold as non sterile.

Device Description

Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.

AI/ML Overview

The provided text describes the performance of "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)" (or other clients private labeling) to demonstrate substantial equivalence to predicate devices, rather than a device that employs AI or requires complex studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this type of device submission.

The acceptance criteria and device performance are based on meeting established consensus standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

DescriptionAcceptance CriteriaReported Device Performance
DimensionMeets ASTM D5250-06Meets ASTM D5250-06
Physical PropertyMeets ASTM D5250-06Meets ASTM D5250-06
Free of PinholeMeets ASTM D5151-06Meets ASTM D5151-06
Residue PowderMeets 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.