A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Device Description

Powder free Latex Examination Gloves, BLACK

AI/ML Overview

The document provided describes a 510(k) premarket notification for "Powder Free Latex Examination Gloves, Black" and outlines the technological characteristics and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ASTM D 3578-05ae2)	Reported Device Performance
Dimensions
Length mm (min.)	240 (all sizes)	240 (all sizes)
Palm Width mm (Small)	-	80 ± 10
Palm Width mm (Medium)	-	95 ± 10
Palm Width mm (Large)	-	105 ± 10
Palm Width mm (X-Large)	-	110 ± 10
Thickness
Cuff mm (min)	0.08 (all sizes)	0.08 (all sizes)
Palm mm (min)	0.10 (all sizes)	0.10 (all sizes)
Finger Tip mm	0.13 (all sizes)	0.13 (all sizes)
Physical Properties (Before ageing)
Tensile Strength	18 Mpa (min)	18 Mpa (min)
Ultimate Elongation	500 % (min)	500 % (min)
Physical Properties (After ageing at 70°C 168 hrs.)
Tensile Strength	14 Mpa (min)	14 Mpa (min)
Ultimate Elongation	500 % (min)	500 % (min)
Pin holes	FDA requirement met	Meets FDA pin hole requirement
Labeling	Labeling claim met	Meets labeling claim

Note: The document states "Performance data is the same as mentioned immediately above," implying the reported device performance met or exceeded the specified criteria in ASTM D 3578-05ae2.

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

The document does not explicitly state the specific sample sizes used for testing each characteristic. However, it references compliance with ASTM D 3578-05ae2 Standard, which would dictate the appropriate sampling plans for each test.

The data provenance is from PT. Maja Agung Latexindo, an Indonesian manufacturer. The study appears to be retrospective in the sense that the results are presented as having already been achieved and verified against established standards.

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

The document does not provide information about the number or qualifications of experts used to establish a "ground truth" for the test set. For medical devices like examination gloves, compliance with established industry standards (like ASTM D 3578-05ae2) and regulatory requirements (like FDA pinhole requirements) serves as the primary benchmark. These standards are developed by expert consensus within their respective fields, but individual expert adjudication of specific test results for this 510(k) submission is not described.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1, none) for the test set is mentioned. Compliance is demonstrated by meeting the quantitative specifications of the ASTM standard.

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

No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging or interpretative tasks where human readers' performance is augmented by AI. For examination gloves, the performance is mechanically and physically evaluated against defined specifications, not through human interpretation.

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

This is not applicable as the device is a physical medical glove, not an algorithm or an AI-powered system. The "performance" refers to the physical and mechanical properties of the glove itself.

7. The Type of Ground Truth Used

The ground truth used is primarily compliance with established industry standards and regulatory requirements, specifically:

ASTM D 3578-05ae2 Standard: This standard defines the physical and performance requirements for medical examination gloves.
FDA pin hole requirement: A specific regulatory requirement for glove integrity.
Labeling claim: Verification that the product's actual performance aligns with its stated labeling.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (latex examination gloves), not an AI algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for a physical device like a glove.

Summary

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PT. MAJA AGUNG LATEXINDO

Manufacturer of Latex Gloves Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang Sumatera Utara - Indonesia
Phone : +62-61 - 8459170 (Hunting) Fax : +62-61 - 8459180 E-mail : mal2510@indosat.net.id

Image /page/0/Picture/3 description: The image is a black and white logo for TUV CERT. The logo is inside of a rectangle with rounded corners. The text "DIN EN ISO 9002 : 1994 Certificate 01 100 009148" is at the bottom of the logo.

JEC - 6 2006

"510 (K)" SUMMARY K062709

(1) Name of applicant	: SUPINAH
Address	: PT. Maja Agung LatexindoJl. Utama No. 98, Puji MulyoSunggal 20352North Sumatra - Indonesia
Phone No.	: 62-61-8459170
Fax No.	: 62-61-8459180
Contact person in U.S.A	: Emmy Tjoeng
Phone No.	: 909-591-8855
Fax No.	: 909-628-6283
(2) Device details
Trade Name	: Powder free Latex Examination Gloves, BLACK
Classification Name	: Powder free Latex Examination Gloves, BLACK
(3) Product Code	: 80 LYY
(4) Equivalent device legally marketed	: Class I Examination Gloves 80 LYY, Powder Free meeting ASTM D 3578-05ae2
(5) Intended use	: Powder free Latex Examination gloves, Black, is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

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Image /page/1/Picture/0 description: The image shows a black and white graphic with a handwritten-style "Ma" in bold black ink. The background consists of horizontal lines, also in black, that run across the image behind the letters. The left side of the image has a thick black vertical bar, creating a framed effect around the letters and lines.

FUNG LA

Sunggal 20352 Deli Serdang nting) Fax : +62-61 - 8459180

Image /page/1/Picture/3 description: The image is a logo for "TUV CERT" with the text "DIN EN ISO 9002: 1994 Certificate 01 100 009145" below it. The logo is enclosed in a rectangular border with rounded corners. The "TUV CERT" text is arranged in a stacked format, with "TUV" on top and "CERT" below it. There are two curved lines above and below the "TUV CERT" text.

500 % (min.)

(6) Technological characteristic of the gloves.

DimensionsSizes	Small	Medium	Large	X-Large
Length mm (min.)	240	240	240	240	± 5
Palm Width mm	80	95	105	110	± 10
Thickness
1. Cuff mm (min)	0.08	0.08	0.08	0.08
2. Palm mm(min)	0.10	0.10	0.10	0.10
3. Finger Tip mm	0.13	0.13	0.13	0.13
b. Physical Properties
		Before ageing		After ageingat 70°C 168 hrs.
Tensile Strength		18 Mpa (min)		14 Mpa (min)

(7) Performance data is the same as mentioned immediately above.

Ultimate Elongation

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

(9) Non-clinical data We certify that our final finished powder free latex examination gloves, black, meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black ink on a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2006

PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Shamrock Marketing Company, Incorporated 5445 Daniel Street Chino, California 91710

Re: K062709

Trade/Device Name: Powder Free Latex Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 8, 2006 Received: November 13, 2006

Dear Ms. Tjoeng:

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 cither 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 - Ms. Tjoeng

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 mount that I Drimal statutes and regulations administered by other Federal agencies. or the For of any / vith 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 alle fishing (21 cm rail 001), and 0017, systems (QS) regulation (21 CFR Part 820); and if requirements as 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) rms reter 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), 11 you dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation i 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suigte Y. Michael MD,

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

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Image /page/4/Picture/0 description: The image shows a logo with the letters "Ma" in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The entire logo is contained within a square, with the bottom left corner of the square being solid black.

A AGUNG LATEX

rer of Latex Gloves

. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang Sumatera Litara - Indonesia +62-61 - 8459170 (Hunting) Fax : +62-61 - 8459180 E-mail : mal2510@indosat.net.id

Image /page/4/Picture/4 description: The image is a logo for "TUV CERT" with the text "DIN EN ISO 9002 : 1994 Certificate 01 100 009146" below it. The logo is contained within a square with rounded corners. The text is in black and the background is white.

ANNEXURE II

INDICATION FOR USE

Applicant

: PT. Maja Agung Latexindo

KO 6270

510(k) Number (if known)

: Powder Free Latex Examination Gloves, Black

Indication for use

Device Name

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Shila f. Mayhing 180

General Hospital

Devices

K 062709

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.