Powdered 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 or finger to prevent contamination between patient and examiner.

Device Description

The Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 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 device:

Device: Powdered Nitrile Blue Examination Gloves, Blue, Non Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimension	D 6319-00aE3	Meets
Physical Properties	D 6319-00aE3	Meets
Freedom from Pinholes	D 6319-00aE3	Meets (implied by meeting FDA 1000 ml Water Leak Test and AQL requirements)
Freedom from Pinholes	FDA 21 CFR 800.20	Meets (implied by meeting FDA 1000 ml Water Leak Test and AQL requirements)
Powder Residue	D 6319-00aE3	10 mg/dm² (specific numerical value provided)
Powder Residue	D6124 - 01	10 mg/dm² (specific numerical value provided)
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in Rabbits	Passes (No primary skin irritation)
Biocompatibility: Dermal Sensitization	Dermal Sensitization	Passes (No contact sensitizer)
Water Leak Test	FDA 1000 ml Water Leak Tes	Meets (specific mention in the conclusion for pinhole AQL)

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

Sample Size: Not explicitly stated. The document refers to "performance test data" but does not specify the number of gloves tested for each characteristic.
Data Provenance: The document states the submitter is PT MAHAKARYA INTI BUANA, located in SUMUT - INDONESIA. The tests were likely conducted by or for this manufacturer, but the specific location of the testing facility is not provided. The study appears to be a prospective series of tests conducted to demonstrate compliance with established standards (ASTM and FDA).

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

Not applicable. This device is a Class I medical device (nitrile examination gloves) and the performance criteria are based on established engineering and safety standards (ASTM and FDA regulations), not on expert interpretations of complex data like medical images. The "ground truth" is defined by the objective pass/fail criteria of these standards.

4. Adjudication method for the test set:

Not applicable. See point 3. The assessment involves physical and chemical tests against defined numerical or qualitative (e.g., "Passes") thresholds within established standards. There is no subjective interpretation requiring an adjudication process.

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:

No. This is not a diagnostic imaging device or an AI-assisted device. Therefore, a MRMC study or AI assistance is not relevant to its evaluation.

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

Not applicable. This device is a physical product (gloves), not an algorithm or software.

7. The type of ground truth used:

The ground truth is based on established industry standards and regulatory requirements. Specifically:
- ASTM D 6319-00aE3: Standard Specification for Nitrile Examination Gloves for Medical Applications.
- FDA 21 CFR 800.20: Regulations for pinhole defects in medical gloves (referenced implicitly through the water leak test).
- ASTM D6124 - 01: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility Testing: Primary Skin Irritation in Rabbits and Dermal Sensitization tests (standard methods for assessing biological safety).
- FDA 1000 ml Water Leak Test: A specific test for glove integrity.

8. The sample size for the training set:

Not applicable. This study does not involve machine learning or AI, and therefore, there is no "training set." The device itself is the product being tested.

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

Not applicable. See point 8.

Summary

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PT. MAHAKARYA INTI BUANA

Image /page/0/Picture/1 description: The image shows a stylized logo with the letters "MB" in a gothic or old English font. The letters are bold and black, with a textured appearance that gives them a three-dimensional effect. The overall design is simple yet striking, with the letters overlapping slightly to create a unified visual element.

K053366
Jalan Sei Belumai

Desa Dalu 10 A Dusun 1 N Tanjung Morawa - 20562 SUMUT - INDONESIA

MAR 3 0 2006

+62-61-7941880 l`el +62-61-7941882 l'ax

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	:	Powdered Nitrile Blue Examination Gloves, Blue.
Non	:	Sterile
Common Name	:	Examination Gloves
Classification Name	:	Nitrile Examination Gloves (Class I)

4.0 Identification of The Legally Marketed Device:

Class I Nitrile Examination Gloves, 80LZA, powdered, 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 Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.

6.0 Intended Use of The Device

The Powdered 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.

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PT. MAHAKARYA INTI BUANA

Image /page/1/Picture/1 description: The image shows a stylized logo with the letters "MB" in a bold, gothic-style font. The letters are large and take up most of the frame. The logo is black and white, with the letters appearing in solid black against a white background. The font style gives the logo a vintage or medieval appearance.

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

I el +62-61-7944880 +62-61-7944882 l·ax

7.0 Summary of The Technological Characteristics of The Device

The Powdered 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 6319-00aE3FDA 21 CFR 800.20	Meets
Powder Residue	D 6319-00aE3D6124 - 01	10 mg/dm²
Biocompatibility	Primary Skin Irritation inRabbits	Passes(No primary skin irritation)
	Dermal Sensitization	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) processes.

10.0 Conclusion

It can be concluded that The Powdered Nitrile Blue Examination Gloves, Blue, Non Sterile will perform according to the gloves 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 device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged on a single line.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA

MAR 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sasitharan Nair Pt. Mahakarya Inti Buana J1 Sei Belumai, Desa Dalu 10 A Dusun I No. 18, Tanjung Morawa, Sumut Indonesia, 20362

Re: K053366

Trade/Device Name: Nitrile Examination Gloves, Powdered, Non Sterile Regulation Number: 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: March 3, 2006 Received: March 15, 2006

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 (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 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. Sasitharan 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 continue 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 (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/dsma/dsmamain.html

Sincerely yours,

Chris

Chiu Lin, Ph.D. Director Division of Dental, Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 《OS-3366

Device Name:

Indications For Use:

NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

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)

Jula P. Murphy 3/30/06

y, General H.
.31

K053344

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.