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

Shanghai Giantmax Plastic Products Powdered Clear Vinyl Examination Glove

AI/ML Overview

The provided text is a 510(k) premarket notification letter for a medical device, specifically a "Shanghai Giantmax Powdered Clear Vinyl Examination Glove." This document is a regulatory approval letter from the FDA and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or technical performance reports.

The letter states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated use. This determination is based on the device meeting the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample size or data provenance for a test set.
Number or qualifications of experts used for ground truth.
Adjudication method for a test set.
Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Results of a standalone (algorithm-only) performance study.
Type of ground truth used.
Sample size for a training set.
How ground truth for a training set was established.

This document focuses on regulatory compliance and substantial equivalence rather than detailed performance study results.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol, with three wavy lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2003

Shanghai Giantmax Plastic Products Corporation C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K032745

Trade/Device Name: Shanghai Giantmax Powdered Clear Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 3, 2003 Received: September 9, 2003

Dear Ms. Goldstein-Falk:

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.

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Page 2 - Ms. Goldstein-Falk

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. 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 (OS) 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricio Curento/Arr

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment #1

Page

510(k) Number (if known): K#032745

Device Name Shanghai Giantmax Plastic Products Powdered Clear Vinyl Examination Glove

Indications For Use:

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)

ice Evaluation (ODE) Concurrence

Cut D. Siesem Branch Chief, Ines, 10/17/03

Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number:

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

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.