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

Device Description

Powder-Free Green Polychloroprene Examination Gloves, Powder-Free Blue Polychloroprene Examination Gloves, Powder-Free Brown Polychloroprene Examination Gloves

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Green Polychloroprene Examination Gloves," "Powder-Free Blue Polychloroprene Examination Gloves," and "Powder-Free Brown Polychloroprene Examination Gloves." It is a regulatory approval letter, not a study describing the acceptance criteria and performance of a device, especially not an AI/ML-based medical device.

Therefore, I cannot provide the requested information because the document does not contain details about:

A table of acceptance criteria and reported device performance (in the context of AI/ML or clinical efficacy)
Sample sizes for test sets or data provenance
Number of experts or their qualifications for establishing ground truth
Adjudication methods
Multi-reader multi-case (MRMC) studies or effect sizes
Standalone algorithm performance
Types of ground truth used
Sample size for training sets
How ground truth for training sets was established

This document is solely an FDA clearance letter for a medical device (examination gloves), confirming its substantial equivalence to previously marketed devices based on its intended use as a barrier to prevent contamination. It does not describe a performance study for complex diagnostic or AI-driven devices.

Summary

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Public Health Service

Food and Orge Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2014

PT Smart Glove Indonesia Mr. Khon Pu Foo Managing Director JL.Pelita Rava No. 5-7 Kimstar. Tanjung Morawa Medan. North Sumatera INDONESIA 20362

Re: K133699

Trade/Device Name(s): Powder-Free Green Polychloroprene Examination Gloves Powder-Free Blue Polychloroprene Examination Gloves Powder-Free Brown Polychloroprene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 26, 2014 Received: June 5, 2014

Dear Mr. Pu Foo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Pu Foo

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

itis fri Dumfit, R6-16, A1 Originia Tejashri Purobit-Sheth, M.D. Tejashri Purofitit-Sheth, M.D. Cilalcal Deputy Director
Director
Clejashri Purofitit-Sheth, M.D. Cilalcal Deputy Director
Cross Crime

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT # 2

Indications for Use

Applicant : Smart Glove Indonesia

510(k) Number (if known): K133699

Device Name: Powder-Free Green Polychloroprene Examination Gloves

Indications For Use:

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

Prescription Use(Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use(21 CFR 801 Subpart C)	√
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Digitally signed by Terrell A. Cunningham -S Date: 2014.07.17 13:29:13 -04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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ATTACHMENT # 2a

Indications for Use

Applicant : Smart Glove Indonesia

510(k) Number (if known): K133699

Device Name: Powder-Free Blue Polychloroprene Examination Gloves

Indications For Use:

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

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 IF NEEDED)

Digitally signed by Terrell A. Cunningham -5 Date: 2014.07.17 13:28:34 -04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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ATTACHMENT # 2b

Indications for Use

Applicant : Smart Glove Indonesia

510(k) Number (if known): K133699

Device Name: Powder-Free Brown Polychloroprene Examination Gloves

Indications For Use:

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

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 IF NEEDED)

Digitally signed by Terrell A. Cunningham -S

Date: 2014.07.17 13:29:50 -04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1_

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.