POWDERED VINYL EXAMINATION GLOVE

• K Number: K052984
• Device Name: POWDERED VINYL EXAMINATION GLOVE
• Manufacturer: TG MEDICAL (CHINA) INCORPORATION
• Date Cleared: 2006-01-11 ( 79 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination Vinyl Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powdered Vinyl Examination Gloves

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

   Performance Metric	Acceptance Criteria	Reported Device Performance
   Substantial Equivalence	The device is substantially equivalent to legally marketed predicate devices.	The device (Powdered Vinyl Examination Gloves) is determined to be substantially equivalent to legally marketed predicate devices.
   Indications for Use	Intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner.	The device meets this indication for use.
   Classification	Classified as Class I, subject to general controls.	The device is classified as Class I.

2. Sample Size for Test Set and Data Provenance:

   • The provided document is a 510(k) clearance letter from the FDA, not a study report. Therefore, it does not specify a "test set" in the context of an algorithm or device performance study with a numerical sample size.
   • The determination of substantial equivalence for devices like examination gloves typically relies on adherence to recognized standards and comparison to predicate devices, rather than a prospective study with a specific test set of patients or samples.
   • Data Provenance: Not applicable in the context of an algorithmic test set. The review is based on the manufacturer's submission demonstrating equivalence to established predicate devices.

3. Number of Experts and Qualifications:

   • This document refers to the FDA's review process. The "experts" involved are the reviewers within the FDA's Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health.
   • The letter is signed by Chiu Lin, Ph.D., Director of that division. While specific qualifications for all individual reviewers are not detailed, it is understood that FDA reviewers are subject matter experts in medical devices and regulatory science. There is no mention of a specific number of "experts" as would be in a consensus study.

4. Adjudication Method:

   • Not applicable in the context of a 510(k) clearance. Substantial equivalence is determined by the FDA based on the submitted information comparing the new device to predicates, not through an adjudication process with multiple readers or experts assessing a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done, as this document is a 510(k) clearance for a physical device (examination gloves), not an AI algorithm. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone Performance Study (Algorithm Only):

   • No, a standalone performance study was not done because this is not an AI algorithm. It is a physical device subject to general controls and substantial equivalence review.

7. Type of Ground Truth Used:

   • The "ground truth" for a 510(k) for a device like examination gloves is established through adherence to recognized performance standards (e.g., for strength, barrier integrity, biocompatibility) and comparison to existing, legally marketed predicate devices. The "ground truth" is that the device performs as safely and effectively as its predicates for its intended use. There isn't a "ground truth" in the sense of expert consensus, pathology, or outcomes data for this type of submission.

8. Sample Size for the Training Set:

   • Not applicable. There is no AI algorithm being "trained" for this device. The concept of a training set is not relevant to the 510(k) clearance of examination gloves.

9. How Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this device type.

Regulation Number and Section

§ 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.