The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the "NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES," based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (ASTM D6319-00a83 & FDA)	Reported Device Performance
Watertight (1000ml)	AQL = 2.5 (Multiple Normal GI)	Pass GI (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) (Single Layer)	Finger: Min 0.05; Palm: Min 0.05	Finger: Min 0.15; Palm: Min 0.12
Physical Properties (Before Aging)
- Tensile Strength (MPa)	Min 14	27 - 30
- Ultimate Elongation (%)	Min 500	780 - 800
Physical Properties (After Aging)
- Tensile Strength (MPa)	Min 14	25 - 27
- Ultimate Elongation (%)	Min 400	670 - 730
Powder Content	Max 2.0 mg/glove	Below 2 mg/glove
Biocompatibility	Pass Primary Dermal Irritation and Guinea Pig Sensitization (Buehler)	The gloves pass the Bio-compatibility Test (implied as meeting criteria)

2. Sample Size and Data Provenance

Sample Size for Test Set: Not explicitly stated for each test. The document refers to "Multiple Normal GI" for the watertight test, suggesting a sampling plan. However, the specific number of gloves tested for each individual parameter (length, width, thickness, tensile strength, etc.) is not provided.
Data Provenance: The document does not specify the country of origin of the data. It is a submission by YTY Industry (Manjung) Sdn Bhd (Malaysia) to the FDA (USA). The testing itself would likely have been conducted at a laboratory associated with the manufacturer or a third-party testing facility. The nature of the study is retrospective in the sense that results are presented as already obtained data to demonstrate compliance with existing standards.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. This study primarily involves performance testing against engineering and material standards, not expert medical interpretation of images or patient conditions.
Qualifications of Experts: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable. This study relies on objective physical and chemical measurements rather than subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images. This document describes the performance of a medical device (examination gloves) based on established physical and chemical standards.

6. Standalone Performance Study

Standalone Performance Study: Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against predefined technical standards (ASTM D6319-00a83 and FDA requirements) without human intervention in the primary measurement process itself. The "algorithm" in this context is the glove itself, and its performance is measured directly.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this study is based on established industry standards and regulatory requirements.
- ASTM D6319-00a83 Standard: This is a recognized material specification standard for patient examination gloves.
- FDA 1000ML Watertight Test: A regulatory requirement specifically for medical gloves.
- FDA Requirements for Powder Content: A specific regulatory limit for powder residue.
- Biocompatibility Standards: Implicitly, the primary dermal irritation and sensitization tests are performed against predefined criteria for what constitutes a "pass."

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device study. This is not an AI/machine learning model that requires training data. The gloves are manufactured and then tested for compliance with specifications.

9. How Ground Truth for the Training Set was Established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Summary

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INDUSTRY (MANJUNG) SDN. BHD.

ompany No : 380830-P) ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia.
Ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Lot 1422-1424, Bata 10 Lokii, Cel 6792443 & 6792445 - Fax : 05-6791188

NOV	1 8 2005
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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	July 20, 2005

3.0 Name of Device

Trade Name: NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES

Common Name	Exam Glove
-------------	------------

Classification Name Patient Examination Glove

4.0 Identification of The Legally Marketed Devices

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a63 and FDA requirements.

5.0 Description of The Device

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.

6.0 The Intended Use of Glove

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, ware or environment.

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KOS2502

Summary of Performance Data: 7.0

Performance data of gloves based on ASTM D6319-00a8 and FDA 1000ML watertight test.

TEST	ASTM D6319-00a3	ON-LINE POWDER FREENITRILE EXAM. GLOVES
1. Watertight (1000ml)	Multiple NormalGI AQL = 2.5	Pass GI	AQL = 2.5
2. Length (mm)SizeXSSMLXL	Min 220Min 220Min 230Min 230-	240 mm minimum for all sizes
3. Palm width (mm)SizeXSSMLXL	70 ± 1080 ± 1095 ± 10111 ± 10-	73 - 7883 - 8893 - 98103 - 107
4. Thickness (mm)(Single Layer)
FingerPalm	Min 0.05Min 0.05	Min 0.15Min 0.12
5. Physical Properties
Before AgingTensile Strength (MPa)Ultimate Elongation (%)	Min 14Min 500		27 - 30780 - 800
After AgingTensile Strength (MPa)Ultimate Elongation (%)	Min 14Min 400		25 - 27670 - 730
6. Powder Content	Max 2.0mg/glove	Below 2 mg/glove

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K052502

8.0 The performance data of the glove as shown above meet the ASTM D6319-00a83 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
10.0 Conclusion

We concluded that the Multiple Private Labeled Non-Sterile, On-Line Powder Free Nitrile Blue & White Color Examination Gloves meets:

ASTM D6319-00a63Standard -
FDA pinhole requirements -
Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83

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K 052502

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Appendix J 510(k) Summary Sheet

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Description and Intended Use of the Gloves........................	Appendix J, Page 1
Product Comparison Chart against ASTM D6319-00aε3 and FDA 1000ML Watertight testStandards........................	Appendix J, Page 2

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2005

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: K052502

Trade/Device Name: Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 10, 2005 Received: November 14, 2005

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 (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 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/industry/support/index.html.

Sincerely yours,

Auey Suleom for
Chin-Lin, Ph.D.

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

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INDICATIONS FOR USE

APPLICANT: YTY INDUSTRY (MANJUNG)
SDN. BHD.

510(k) NUMBER: R052502

DEVICE NAME: NON-STERILE, POWDER-FREE NITRILE
BLUE & WHITE EXAMINATION GLOVES

Indications For Use:

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

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)

Shule H. Murphy, KS

on Sign-On)
of Anesthesiology, General Hospital, on Control, Dental Devices

K052582

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.