Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner

Device Description

The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

AI/ML Overview

The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

CHARACTERISTICS	STANDARDS	ACCEPTANCE CRITERIA (Implied by "Meets" or specified values)	DEVICE PERFORMANCE
Dimension	D 3587 -01 ae²	Conformance to ASTM D 3587 -01 ae²	Meets (Conforms to ASTM D 3587 -01 ae²)
Physical Properties	D 3587 -01 ae²	Conformance to ASTM D 3587 -01 ae²	Meets (Conforms to ASTM D 3587 -01 ae²)
Freedom from Pinholes	D 3587 -01 ae² & FDA 21 CFR 800.20	Conformance to ASTM D 3587 -01 ae² & FDA 21 CFR 800.20	Meets (Conforms to ASTM D 3587 -01 ae² & FDA test)
Powder Free Residue	D 3587 -01 ae² & D6124 - 01	< 2 mg/glove	< 2 mg/glove
Water Soluble Protein Content	D 3587 -01 ae² & D 5712 - 99	< 50 µg/g	< 50 µg/g
Biocompatibility:
Primary Skin Irritation	Primary Skin Irritation in Rabbits	No Primary Skin Irritation	Passes (No Primary Skin Irritation)
Dermal Sensitization	Dermal Sensitization	No contact sensitizer	Passes (No contact sensitizer)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., for dimension, pinholes, etc.). It only indicates that the device "Meets" the specified standards.

Data Provenance: The manufacturing company is PT Mandiri Inti Buana, located in Tanjung Morawa, SUMUT - INDONESIA. It is implied that the testing was conducted by or for this manufacturer, although the specific testing location is not mentioned. The document does not specify whether the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert consensus on diagnostic images or clinical outcomes. The "ground truth" is established by the defined ASTM and FDA test methods and their acceptance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance is determined by direct measurement against quantitative and qualitative standards using defined test methods, not by expert adjudication of subjective assessments.

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 device is a medical glove, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is a physical product (medical glove), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements:

ASTM standard D 3578-01 ae²: This is a standard specification for rubber examination gloves.
FDA 21 CFR 800.20 (for Freedom from Pinholes) and FDA 1000 ml Water Leak Test: These are regulatory requirements for pinhole detection in medical gloves.
D6124 - 01: Standard test method for residual powder on medical gloves.
D 5712 - 99: Standard test method for analysis of protein in natural rubber latex products.
Primary Skin Irritation in Rabbits and Dermal Sensitization tests: These are standard biological evaluation tests to assess biocompatibility.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image shows the letterhead for PT Mandiri Inti Buana. The letterhead includes the company name, address (Jalan Sei Belumai, Desa Dalu 10 A Dusun 1, Tanjung Morawa - 20362, SUMUT - INDONESIA), telephone number (+62-61-7944880), and fax number (+62-61-7944882). The date "OCT - 6 2005" is also present, along with the number K051987.

510 (K) SUMMARY

Submitter:
Name	:	PT MANDIRI INTI BUANA
Address	:	Jl. Sei Belumai, Desa Dalu 10 A Dusun 1Tanjung 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) Flexiskin and2) Multiple or Customers' Trade Name
Device Name	Polymer Coated Latex Examination Gloves, PowderFree, Non Sterile
Common Name	Examination Gloves
Classification Name	Patient Examination Gloves (Class I)

Identification of The Legally Marketed Device: 4.0

Class I Examination gloves, 80 LYY, Powder Free, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

Description of The Device 5.0

The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile mects all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

Intended Use of The Device 6.0

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

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

Image /page/1/Picture/0 description: The image shows a stylized logo or emblem consisting of the letters "MB" in a bold, gothic-style font. The letters are rendered in solid black, creating a strong contrast against the white background. The design appears to be hand-drawn or digitally created to mimic a hand-drawn aesthetic, with irregular edges and thick strokes that give it a somewhat rough and edgy appearance. The overall impression is that of a logo for a brand or organization with a bold, somewhat aggressive identity.

PT MANDIRI INTI BUANA

Jalan Sei Bclumai Desa Dalu 10 A Dusun 1 Taniung Morawa -- 20362 SUMUT - INDONESIA

+62-61-7944880 ان ا 162-61-7944882 Fax

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

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimension	D 3587 -01 ae²	Meets
Physical Properties	D 3587 -01 ae²	Meets
Freedom from Pinholes	D 3587 -01 ae²FDA 21 CFR 800.20	Meets
Powder Free Residue	D 3587 -01 ae²D6124 - 01	< 2 mg/glove
Water Soluble ProteinContent	D 3587 -01 ae²D 5712 - 99	< 50 µg/g
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 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 Clinical Performance Data ಕ್ಕೆ ()

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 Polymer Coated Latex Examination Gloves, Powder Free, 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 devices.

{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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring four abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

OCT 6 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Sasitharan Nair TOM Manager Pt. Mandiri Inti Buana Jalan Set Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa, Sumut INDONESIA 20362

Re: K051987

Trade/Device Name: FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYY Dated: September 20, 2005 Received: September 29, 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 (111) vice 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. or the ret 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 and ifoune (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms retet 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), n you domact 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 maj volum 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,

Chiu-Liang PhD

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):

Device Name: POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE Indications For Use:

Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is 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) CRF801.109

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shilu A. Murphy, MD 11/4/15
(Division Sign Off)

(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Der

510(k) Number: N051987

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.