Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

AI/ML Overview

This document describes the acceptance criteria and performance of the PT. Mandiri Inti Buana Latex Examination Gloves, Powdered, Non-Sterile.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	ASTM D 3578 - 01a2	Meets
Physical Properties	ASTM D 3578 - 01a2	Meets
Freedom from Pinholes	ASTM D 3578 - 01a2 & FDA 21 CFR 800.20 (1000 ml Water Leak Test)	Meets
Powder Amount	ASTM D 3578 - 01a2 & ASTM D 6124 - 01	< 10 mg/dm² / 39.15 mg/glove
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in Rabbits (Passes)	Passes (No primary skin irritation)
Biocompatibility: Dermal Sensitization	Dermal Sensitization (Passes)	Passes (No contact sensitizer)

2. Sample size used for the test set and data provenance:

The document does not explicitly state the sample size used for the test set for each of the performance characteristics. The tests likely fall under quality control or material testing conducted by the manufacturer.
Data provenance: The testing was performed by PT. Mandiri Inti Buana, an Indonesian company. The data is retrospective in the context of this 510(k) submission, as it represents pre-market testing results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The characteristics being tested are objective physical and chemical properties of a medical device (gloves), not diagnostic interpretations requiring expert consensus. The "ground truth" is established by adherence to recognized ASTM and FDA standards.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image reading) where multiple experts might disagree. Here, the tests are objective measurements against defined standards.

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:

This information is not applicable. The device is a physical medical device (examination gloves), not an AI-powered diagnostic tool, and therefore MRMC studies for AI assistance are not relevant.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's performance is based on established industry standards and regulatory requirements. Specifically, ASTM International standards (D 3578 - 01a2, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test). For biocompatibility, the ground truth is established by standard biological testing protocols (Primary Skin Irritation in Rabbits and Dermal Sensitization assays) designed to demonstrate safety.

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of testing a physical medical device like examination gloves. The manufacturing process is subject to quality control, but not in the same way an AI algorithm is "trained."

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

This information is not applicable, as there is no training set for this device.

Summary

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PT. Mandiri Inti Buana

MAY 21 2003

Jalan Listrik No, 6 Medan-20112 INDONESIA

62-81-45860
62-81-46860

510 (K) SUMMAR

1.0 Submitter :

Name	PT. Mandiri Inti Buana
Address	Jl. Listrik No.6
	Medan - Indonesia, 200112.
Phone No.	+61 4566506
Fax No.	+61 4566806

Date of Summary Prepared :

Contact Person :

2.0

Name	:	Mr. Ng Poy Sir
Phone No.	:	+61 4566506
Fax No.	:	+61 4566808

Name of the device : 3.0

Trade Name	1). Flexiskin, and2). Multiple or Customers' Trade Name
Device Name	: Latex Examination Gloves, Powdered, Non-Sterile
Common Name	: Examination Gloves
Classification Name	: Patient Examination Gloves (Class 1)

ldentification of The Legally Marketed Device : 4.0

Class I patient examination gloves, 80LYY, powdered, that meets all the requirements of ASTM standard D 3578 - 01a82 and FDA 1000 ml Water Leak Test.

Description of The Device : 5.0

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

Intended Use of the Device : 6.0

The Latex Examination Glove, Powdered, Non Sterite ia a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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PT. Mandiri Inti Buana

Jalan Liatrik No. 6 Medan-20112 INDONESIA

KO3/020/51

+62-61-4666506 Tel + 62-81-4566806 883

Summary of The Technological Characteristics of The Device : 7.0

The Latex Examination Gloves, Powdered, Non Sterile are summanized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	D 3578 - 01a2	Meets
Physical Properties	D 3578 - 01a2	Meets
Freedom from Pinholes	D 3578 - 01a2FDA 21 CFR 800.20	Meets
Powder Amount	D 3578 - 01a2D 6124 - 01	< 10 mg/dm²/ 39.15 mg/glove
Biocompatability	Primary Skin Irritation in Rabbits	Passes(No primary skin irritation)
	Dermal Sensitization	Passes(No contact sensitizer)

Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

Substantial Equivalent Based on Assessment of Cilinical Performance Data 9.0

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Conclusion 10.0

It can be concluded that the Latex Examination Gloves, Powdered, Non Sterlie will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

Page 2 of 2

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines that create a sense of unity and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Mr. Ng Poy Sin Director PT. Mandiri Inti Buana Jl. Listrik No. 6 Medan, INDONESIA 20112

Re: K031020

Trade/Device Name: Latex Examination Gloves, Powdered, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 23, 2003 Received: April 28, 2003

Dear Mr. Sin:

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. Sin

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 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 (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 Riens

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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PT. Mandiri Inti Buana

Jalan Listrik No. 6 Medan-20112 INDONESIA

Tel +62-61-4566506 Fax +62-61-4566806

INDICATIONS FOR USE

Applicant

: PT. Mandiri Inti Buana

510(k) Number (if known)

Device Name

: LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
OR Over-The-Counter

Chis S. Lin

510(k) Numbe

sthesionav General Hr

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.