A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Description

POWDER FREE LATEX EXMAINATION GLOVES

AI/ML Overview

This document, K071322, is a 510(k) premarket notification for Powder Free Latex Examination Gloves. It is a regulatory clearance letter from the FDA, and as such, it does not contain the detailed technical study information typically found in a scientific publication or clinical trial report that describes acceptance criteria and device performance in the way requested.

Therefore, I cannot provide a direct answer to your request regarding acceptance criteria and a study proving the device meets them from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for this class of device based on comparisons to existing products, rather than presenting a novel study designed to establish new performance criteria.

Here's why each of your requested points cannot be extracted from this specific document:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., tensile strength, viral barrier effectiveness) or present results from tests against such criteria. It's a regulatory clearance letter, not a performance report.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned.
Adjudication method: Not applicable or mentioned.
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: Not applicable. This device is a physical glove, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical glove, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." For gloves, "ground truth" might refer to established physical properties and barrier effectiveness, but this document does not detail the testing.
The sample size for the training set: Not applicable. Examination gloves do not typically involve "training sets" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

Ms. Seah Bee Hoon Chief Executive Officer Quality Gallant Sdn. Bhd. Lot 1874, Jalan Kampung Dew. Simpang Halt, Taiping, Perak, MALAYSIA 34700

Re: K071322

Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 22, 2007 Received: July 2, 2007

Dear Ms. Hoon:

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. Hoon

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 (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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

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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QUALITY GALLANT SDN BHD Lot 1874; Jalan Kampung Dew, Simpang Halt, 34700, Taiping, Perak, Malaysia

3.0 Indication for Use Statement

Indications for Use

Quality Gallant Sdn. Bhd. Applicant :

510(k) Number (if known): K071322

Device Name: POWDER FREE LATEX EXMAINATION GLOVES

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

Sheila A Murphy, MD

("Tision Sign-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K071322

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.