Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) 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 Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PT. Mandiri Inti Buana examination gloves:

Overview:

This submission describes a Class I medical device (Powder Free Latex Examination Gloves, Non-Sterile) and seeks a 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The "study" here refers to non-clinical performance testing conducted to demonstrate compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

CHARACTERISTICS	ACCEPTANCE CRITERIA (STANDARDS)	REPORTED DEVICE PERFORMANCE
Dimensions	D 3578 - 01ae2	Meets
Physical Properties	D 3578 - 01ae2	Meets
Freedom from Pinholes	D 3578 - 01ae2, FDA 21 CFR 800.20 (FDA 1000 ml Water Leak Test)	Meets
Powder Residue	D 3578 - 01ae2, D 6124 - 01	< 2 mg/glove
Water Soluble Protein Content	D 3578 - 01ae2, D 5712 - 99	< 50 µg/gram
Biocompatibility	Primary Skin Irritation in Rabbits, Dermal Sensitization (standards not explicitly named but implied by the tests)	Passes (No primary skin irritation), Passes (No contact sensitizer)

Notes on the "Study" and Performance Data:

The document describes non-clinical performance testing that demonstrates the device meets the specified ASTM standards and FDA requirements. This is not a "study" in the traditional sense of a clinical trial or a comparative effectiveness study involving human subjects or experts, but rather a series of laboratory tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits for biocompatibility). It simply states that the device "Meets" the standards or provides a quantitative result (e.g., "< 2 mg/glove"). The sample sizes would be dictated by the specific ASTM and FDA test methods referenced (e.g., D 3578-01ae2, D 6124-01, D 5712-99, and FDA 21 CFR 800.20).
Data Provenance: The document does not explicitly state the country of origin for the test data itself. The manufacturer is located in Indonesia. The testing would have been conducted in a laboratory, but the location of that lab is not specified. The data is retrospective in the sense that the tests were performed and analyzed before the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Experts: Not applicable in the context of this device. The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by the ASTM standards and FDA regulations themselves.
Qualifications: The individuals performing the tests would be qualified lab technicians, but their specific number and qualifications are not mentioned as they are performing established, standardized tests, not making subjective expert judgments like in image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The tests are objective measurements against established standards. There is no subjective interpretation requiring an adjudication process. Results are either "Meets" or they don't, or they fall within a specified quantitative range.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases and their performance (with and without AI assistance) is compared. These gloves are a Class I barrier device, not a diagnostic tool requiring human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Standalone Performance: Not applicable. This device does not involve an algorithm or AI. Its performance is assessed through physical, chemical, and biological laboratory tests, not automated analysis.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on established and objective physical, chemical, and biological standards. Specifically:
- ASTM standards (e.g., D 3578-01ae2 for dimensions, physical properties, freedom from pinholes; D 6124-01 for powder residue; D 5712-99 for water soluble protein content).
- FDA regulations (e.g., 21 CFR 800.20 for the 1000 ml Water Leak Test for pinholes).
- Biocompatibility test methods (Primary Skin Irritation in Rabbits, Dermal Sensitization), which have established protocols and endpoints for determining "Pass" or "Fail."

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth Establishment: Not applicable, as there is no training set.

Summary

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PT. Mandiri Inti Buana

JUN 3 0 2003

Jalan Listrik No. 6 Medan-20112 INDONESIA

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

510 (K) SUMMARY

4031754

1.0 Submitter :

Name	: PT. Mandiri Inti Buana
Address	: Jl. Listrik No. 6Medan - INDONESIA, 20112.
Phone No.	: +61 4566506
Fax No.	: +61 4566806

Date of Summary Prepared :

2.0 Contact Person :

Name	: Mr. Ng Poy Sir
Phone No.	: +61 4566506
Fax No.	: +61 4566806

3.0 Name of the device :

Trade Name	1).	Flexiskin, and
	2).	Multiple or Customers' Trade Name
Device Name	:	Powder Free Latex Examination Gloves, Non-SterileContains 50 micrograms or less of Total Water Extractable Protein pergram
Common Name	:	Examination Gloves
Classification Name	:	Patient Examination Gloves (Class I)

4.0 ldentification of The Legally Marketed Device :

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

5.0 Description of The Device :

6.0 Intended Use of the Device :

The Powder Free Latex Examination Glove, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is 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

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

Summary of The Technological Characteristics of The Device : 7.0

The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	D 3578 - 01ae2	Meets
Physical Properties	D 3578 - 01ae2	Meets
Freedom from Pinholes	D 3578 - 01ae2FDA 21 CFR 800.20	Meets
Powder Residue	D 3578 - 01ae2D 6124 - 01	< 2 mg/glove
Water Soluble Protein Content	D 3578 - 01ae2D 5712 - 99	< 50µg/gram
Biocompatability	Primary Skin Irritation inRabbitsDermal Sensitization	Passes(No primary skin irritation)Passes(No contact sensitizer)

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

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

9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

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

10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2003

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

Re: K031754

Trade/Device Name: Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 20, 2003 Received: June 23, 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 Runny

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 +62-61-4566806 Fax

INDICATIONS FOR USE

Applicant	: PT. Mandiri Inti Buana
510(k) Number (if known)	: K031754
Device Name	: POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE. (Contains 50 micrograms or less of Total Water Extractable Protein per gram)

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K031754

age 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.