This Non-Sterile, Powder-Free, Black Nitrile 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.

Device Description

Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The acceptance criteria and device performance for the Non-Sterile, Powder-Free, Black Nitrile Examination Gloves are detailed below, based on the provided document K061553.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (ASTM D6319-00a)	Reported Device Performance (Powder Free Nitrile Examination Gloves)
Watertight (1000ml)	Multiple Normal GII, AQL = 2.5	Pass GII, AQL = 2.5
Length (mm)	Min 220 (XS, S), Min 230 (M, L)	240 mm minimum for all sizes
Palm width (mm)	XS: 70 ± 10, S: 80 ± 10, M: 95 ± 10, L: 111 ± 10	XS: 73-78, S: 83-88, M: 93-98, L: 103-107
Thickness (mm)	Finger: Min 0.05, Palm: Min 0.05	Finger: Min 0.08, Palm: Min 0.08
Physical Properties (Before Aging)	Tensile Strength: Min 14 MPa, Ultimate Elongation: Min 500%	Tensile Strength: 15-21 MPa, Ultimate Elongation: 550-630%
Physical Properties (After Aging)	Tensile Strength: Min 14 MPa, Ultimate Elongation: Min 400%	Tensile Strength: 14-22 MPa, Ultimate Elongation: 520-610%
Powder Content	Max 2.0 mg/glove	Below 2 mg/glove

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

Sample Size: The document does not explicitly state the exact sample size used for each individual test (e.g., number of gloves tested for watertightness, length, etc.). However, for the watertight test, it references "Multiple Normal GII" with an AQL (Acceptable Quality Level) of 2.5, which implies a statistically determined sample size based on lot size, as per ASTM standards for inspection.
Data Provenance: The document does not specify the country of origin of the data. It is presented as summary performance data based on ASTM D6319-00a and FDA 1000ML watertight tests conducted by the manufacturer, YTY Industry (Manjung) Sdn Bhd, located in Malaysia. The nature of these tests (dimensional, physical property, chemical testing) suggests they are laboratory-based tests rather than human subject data, thus the terms "retrospective or prospective" are not directly applicable in the biological or clinical sense but rather describe the execution of a standardized test.

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

This device is a medical glove, and the "ground truth" for its performance is established through adherence to standardized physical and chemical specifications, not through expert clinical interpretation. The performance data is objective and measurable against the ASTM D6319-00a standard. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense is not applicable here.

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

Not applicable. The "tests" are objective measurements against a standard, not interpretations requiring adjudication.

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.

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

Not applicable. This device is a 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 the objective measurements and specifications defined by the ASTM D6319-00a standard for nitrile examination gloves. These include physical properties (length, width, thickness, tensile strength, elongation) and chemical properties (powder content), as well as a watertightness test.

8. The sample size for the training set:

Not applicable. This device is a physical product, a medical glove, and does not involve AI or machine learning models that require a training set.

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

Not applicable. There is no training set for this device.

Summary

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K061553

and the comments of the comments of the comments of

JUL 1 7 2006

Appendix J 510(k) Summary Sheet

Description and Intended Use of the Gloves........................	Appendix J, Page 1
Product Comparison Chart against ASTM D6319-00ae3and FDA 1000ML Watertight test Standards........................	Appendix J, Page 2

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Image /page/1/Picture/0 description: The image shows a black and white drawing of a symbol. The symbol is composed of a horizontal curved line at the top, resembling a crescent. Below the curved line, there are two vertical rectangular shapes, with smaller horizontal rectangular shapes on either side of the top rectangular shape. The symbol appears to be abstract and stylized.

YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188

APPENDIX-J

1.0	SMDA 510 (K) SUMMARY
2.0	Submitter	YTY Industry (Manjung) Sdn BhdLot 1422-1424, Batu 10 Lekir32020 SitiawanPerak Darul RidzuanMALAYSIA
	Tel	605-6792288
	Fax	605-6791188
	Name of Contact Person	1. MR. MOH UNG NANG
	Official Correspondence	2. MS. JANNA TUCKER
	Date of Summary Prepared	May 2, 2006
3.0	Name of Device
	Trade Name:	Non-Sterile, Powder-Free, Black Nitrile Examination Gloves.
	Common Name:	Synthetic Rubber Examination Gloves

Classification Name: Patient Examination Glove, Powder Free

4.0 Identification of The Legally Marketed Devices

Black Colour Powder Free Nitirle Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880,6250). It meets all the current specifications listed under the ASTM Specification D6319-00at Standard Specification for Nitrile Gloves for Medical Application.
EQui VALENT TO KOST 50Z EXCEPT FOR COLOR.

5.0 Description of The Device

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6.0 The Intended Use of Glove

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

7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D6319-00a and FDA 1000ML watertight test.

TEST	ASTM D6319-00a $⁳$	POWDER FREE NITRILE EXAMINATION GLOVES
1. Watertight (1000ml)	Multiple NormalGIIAQL = 2.5	Pass GIIAQL = 2.5
2. Length (mm)Size XSSMLXL	Min 220Min 220Min 230Min 230-	240 mm minimum for all sizes
3. Palm width (mm)Size XSSMLXL	$70 \pm 10$$80 \pm 10$$95 \pm 10$$111 \pm 10$-	73 - 7883 - 8893 - 98103 - 107
4. Thickness (mm)(Single Layer)FingerPalm	Min 0.05Min 0.05	Min 0.08Min 0.08
5. Physical PropertiesBefore AgingTensile Strength (MPa)Ultimate Elongation (%)After AgingTensile Strength (MPa)Ultimate Elongation (%)	Min 14Min 500Min 14Min 400	15 - 21550 - 63014 - 22520 - 610
6. Powder Content	Max 2.0mg/glove	Below 2 mg/glove

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8.0 The performance data of the glove as shown above meet the ASTM D6319-00a E-3 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
10.0 Conclusion

We conclude that the Multiple Private Labeled Non-Sterile Black Colour Powder Free Nitirle Examination Gloves meets:

-ASTM D6319-00a Standard
-FDA pinhole requirements
Are below the maximum Powder Residual Content as specified in ASTM -D6319-00aE3

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, representing the department's focus on health and well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550

Re: K061553

Trade/Device Name: Non-Sterile, Powder-Free, Black Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 1, 2006 Received: June 7, 2006

Dear Ms. Tucker:

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 - Ms. Tucker

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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutta Y. Michaud

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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INDICATIONS FOR USE

APPLICANT:	YTY INDUSTRY (MANJUNG) SDN.BHD.
510(k) NUMBER:
DEVICE NAME:	NON-STERILE, POWDER-FREE, BLACK NITRILEEXAMINATION GLOVE

Indications For Use:

Prescription Use....................... Per 21 CFR 801.109

AND/OR

Over-The-Counter Use ... X .......... (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)

Shule K. Mupadhyay, M.D. 2/14/04

n of Anesthesiology, General Hospital, on Control, Dental Devices

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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.