Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.

Device Description

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimension	D 6319-00aE3	Meets
Physical Properties	D 6319-00aE3	Meets
Freedom from Pinholes	D 6319-00aF3FDA 21 CFR 800.20	Meets
Powder Residue	D 6319-00aE3D6124 - 01	< 2 mg/glove
Biocompatibility (Primary Skin Irritation in Rabbits)	Standard not specified in table	Passes (No primary skin irritation)
Biocompatibility (Dermal Sensitization)	Standard not specified in table	Passes (No contact sensitizer)

Study Details:

Based on the provided document, the device in question is a medical glove, a Powder Free Nitrile Examination Glove, Blue, Non Sterile. The document describes a non-clinical performance study and explicitly states that clinical data is not needed for gloves or for most devices cleared by the 510(k) processes.

Therefore, most of the requested information for a typical medical AI device study (sections 2, 3, 4, 5, 6, 7, 8, 9) is not directly applicable or available in this context. Here's what can be inferred:

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

This is provided in the first table above, extracted directly from the document.

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

Sample Size: Not explicitly stated for each test. The tests are for manufacturing quality control (e.g., pinholes, dimensions, physical properties, powder residue) and biocompatibility. For manufacturing tests, samples would be taken from production batches. For biocompatibility, animal testing (rabbits) was used.
Data Provenance: The tests are likely conducted by the manufacturer, PT. MAHAKARYA INTI BUANA, based in SUMUT - INDONESIA. The exact country of origin of the data is Indonesia, as it's a submission from an Indonesian company.
Retrospective or Prospective: These are likely prospective tests performed on the manufactured product to ensure compliance with standards.

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

Not applicable in the context of device performance testing for medical gloves. The "ground truth" is established by the specified ASTM and FDA standards for physical and chemical properties and laboratory animal testing for biocompatibility. These standards define the objective criteria.

4. Adjudication method for the test set:

Not applicable. Performance against defined objective standards (ASTM, FDA) for physical and chemical properties does not involve human adjudication in the same way clinical image interpretation might. Biocompatibility testing follows established laboratory protocols.

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:

Not applicable. This is a medical glove, not an AI-powered diagnostic device.

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

Not applicable. This is a medical glove, not an AI-powered device. The "device performance" reported is the standalone performance of the glove itself against physical and chemical standards.

7. The type of ground truth used:

Objective Standards: The ground truth for dimension, physical properties, freedom from pinholes, and powder residue is based on the objective criteria defined in the respective ASTM standards (D 6319-00aE3, D 6319-00aF3, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test).
Biocompatibility Testing Protocols: For biocompatibility (Primary Skin Irritation and Dermal Sensitization), the ground truth is established by the results of standardized animal (rabbit) testing protocols, where "Passes" means "No primary skin irritation" and "No contact sensitizer."

8. The sample size for the training set:

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process is refined, but this is not a training set in the AI sense.

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

Not applicable for the reasons stated above.

In summary, the provided document focuses on demonstrating substantial equivalence for a medical glove through non-clinical performance data against established industry standards and regulatory requirements. It explicitly states that clinical data is not required for this type of device within the 510(k) pathway.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: This image contains the logo and contact information for PT. Mahakarya Inti Buana. The address is Jalan Sei Belumai, Desa Dalu 10 A Dusun 1 No. 18, Tanjung Morawa - 20362, SUMUT - INDONESIA. The telephone number is +62-61-7944880, and the fax number is +62-61-7944882.

Summary of The Technological Characteristics of The Device 7.0 The Powder Free Nitrile Examination Gloves, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimension	D 6319-00aE3	Meets
Physical Properties	D 6319-00aE3	Meets
Freedom from Pinholes	D 6319-00aF3FDA 21 CFR 800.20	Meets
Powder Residue	D 6319-00aE3D6124 - 01	< 2 mg/glove
Biocompatibility	Primary Skin Irritation inRabbits	Passes(No primary skin irritation)
	Dermal Sensitization	Passes(No contact sensitizer)

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

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 Clinical Performance Data 9.0

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

10.0 Conclusion

It can be concluded that The Powder Free Nitrile Blue Examination Gloves, Blue, Non Sterile will perform according to the gloves performance standards referenced in Section (7) above and mect ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed device.

{1}------------------------------------------------

PT. MAHAKARYA INTI BUANA

Image /page/1/Picture/1 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic-style font. The letters are large and bold, with intricate details and serifs that are characteristic of the gothic typeface. The black ink contrasts sharply against the white background, making the letters stand out prominently.

Jalan Sei Belt Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa - 20362 SUMUT - INDONESIA

Tel +62-61-7944880 +62-61-7944882 lax

510 (K) SUMMARY

1.0 Submitter:

Name	:	PT MAHAKARYA INTI BUANA
Address	:	Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18Tanjung Morawa – 20362SUMUT - INDONESIA
Phone No.	:	+62-61-7944880
Fax No.	:	+62-61-7944882

Date of Summary Prepared:

2.0 Contact Person:

Name	:	Mr. Sasitharan Nair
Phone	:	+62-61-7944880
Fax No.	:	+62-61-7944882

3.0 Name or the device:

Trade Name	1) Senstouch and2) Multiple or Customers' Trade Name
Device Name	Powder Free Nitrile Examination Gloves, Blue, Non Sterile
Common Name	Examination Gloves
Classification Name	Nitrile Examination Gloves (Class I)

Identification of The Legally Marketed Device: 4.0

Class I Nitrile Examination Gloves, 80LZA, powder free, that meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.

5.0 Description of The Device

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.

6.0 Intended Use of The Device

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and three lines representing its legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P Sasitharan Nair Quality Regulation Manager PT. MAHAKARYA INTI BUANA J1. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 Tanjung Morawa-20362 SUMUT-INDONESIA

Re: K053657

Trade/Device Name: Powder Free Nitrile Examination Gloves, Non-Sterile (Blue) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 21, 2005 Received: December 5, 2005

Dear Mr. Nair:

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.

{3}------------------------------------------------

Page 2 - Mr. Nair

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 (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.

Saytie Y. Michael Davis.

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): 《 05 3657

Device Name:

Indications For Use:

SOWDER FREE NITRILE EXAMINATION GLOVES, NON-STERITE (BLUE)

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sida M. Murphy KC 2/1/06

Introduction to Computer Organization

Computer Abstractions and Technology

K053657

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.