A 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.

Device Description

VINYL EXAMINATION GLOVES, POWDER-FREE

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for Vinyl Examination Gloves, Powder-Free. This type of document does not contain the information requested in your prompt regarding acceptance criteria and study details.

The provided text simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or test results.
Sample size used for the test set and the data provenance: No device testing details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review details are provided.
Adjudication method for the test set: Not applicable as no test set details are provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a medical glove, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
The type of ground truth used: No ground truth details are provided.
The sample size for the training set: Not applicable as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

The 510(k) process for devices like examination gloves primarily relies on demonstrating substantial equivalence to existing predicate devices, often through adherence to recognized standards (e.g., ASTM standards for glove performance). The detailed testing reports supporting this substantial equivalence are typically submitted by the manufacturer to the FDA but are not generally part of the publicly released 510(k) clearance letter itself.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2002

Shandong Jiazhan Plastics Products Company Limited C/O Ms. Janna Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550

Re: K023235

Trade/Device Name: Vinyl Examination Gloves, Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 24, 2002 Received: September 27, 2002

Dear Ms. Tucker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

{1}------------------------------------------------

Page 2 -- Ms. Tucker

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Timothy A. Ulatowski Director V Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

INDICATIONS FOR USE

APPLICANT:

SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD.

510(k) NUMBER:

KD23235

DEVICE NAME:

VINYL EXAMINATION GLOVES. POWDER-FREE

A 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Clim S. Loin

Division Sign-Off) (Division Sign-O'l)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K02335

EXHIBIT B

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.