An Examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

STERILE PATIENT EXAMINATION GLOVES - POWDERFD

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for "Sterile Patient Examination Gloves, Powdered." It is not a study report or a document describing the acceptance criteria or performance of a medical device based on a clinical or technical study.

Therefore, most of the requested information cannot be extracted from the provided text. The document primarily serves as an official notification that the device has been deemed "substantially equivalent" to predicate devices and can be marketed.

Here's what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. This document does not contain acceptance criteria for performance benchmarks, nor does it report specific device performance data. The 510(k) process for patient examination gloves typically relies on adherence to recognized standards (e.g., ASTM standards for physical properties, biocompatibility) rather than complex clinical studies with performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices. The substantial equivalence determination means it met these standards but the specific acceptance criteria and performance data are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. No test set, sample size, or data provenance is mentioned as this is not a study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. This information is irrelevant to a 510(k) clearance for examination gloves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. Not applicable to this type of regulatory document.

5. 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

Cannot be extracted. This document is for examination gloves, not an AI-powered diagnostic device. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be extracted. This document pertains to a physical medical device (gloves), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be extracted. No ground truth defined in this context. Substantial equivalence for gloves typically relies on compliance with material specifications, mechanical properties, and biocompatibility standards.

8. The sample size for the training set

Cannot be extracted. No training set is involved for this type of device and regulatory submission.

9. How the ground truth for the training set was established

Cannot be extracted. Not applicable.

Summary from the provided document:

The provided text is an FDA 510(k) clearance letter for "Sterile Patient Examination Gloves, Powdered." It confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. The letter explicitly states the device's indications for use: "An 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."

This document does not contain information about specific performance data, acceptance criteria metrics, sample sizes for studies, expert qualifications, or details typically found in scientific study reports for complex medical devices or AI algorithms.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Mr. Joseph J. E. Pereira Managing Director Sanrea Healthcare Private Limited Plot No. 14-C. Cochin Special Economic Zone, Kakkanad, Cochin-682037 Kerala, INDIA

Re: K023915

Trade/Device Name: Sterile Patient Examination Gloves, Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 15, 2003 Received: January 21, 2003

Dear Mr. Pereira:

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 - Mr. Pereira

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 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 vours.

Susan Punner

Susan Runner, DDS, MA Interim 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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A HEALTHCARE PRIVATE I

T NO. 14-C, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD, COCHIN 0 : 422514, 422826, 423211, Fax : 91 484 - #22541, E-mail : sanrea@ysnl.net

ENCLOSURE-II

INDICATIONS FOR USE

APPLICANT

SANREA HEALTHCARE PVT LTD .

510 (k) NO

K623915

DEVICE NAME

STERILE PATIENT EXAMINATION GLOVES - POWDERFD

INDICATIONS FOR USE.

An Examination glove is a disposable device intended for medical purposes that is wom 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)

Clim S. Lim
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K023915

Prescription Use (Pcr 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.