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.

Device Description

Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for medical Application.

AI/ML Overview

This document describes the acceptance criteria and performance data for non-sterile, powder-free nitrile examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (ASTM D6319-00a & FDA)	Reported Device Performance (POWDER FREE NITRILE EXAMINATION GLOVES)
1. Watertight (1000ml)	Multiple Normal GI, AQL = 2.5	Pass GI, AQL = 2.5
2. Length (mm)	XS: Min 220, S: Min 220, M: Min 230, L: Min 230, XL: Min 230	240 mm minimum for all sizes
3. Palm Width (mm)	XS: 70±10, S: 80±10, M: 95±10, L: 111±10, XL: 111±10	73-78 (XS), 83-88 (S), 93-98 (M), 103-107 (L), 103-107 (XL)
4. Thickness (mm) (Single Layer)
Finger	Min 0.05	Min 0.08
Palm	Min 0.05	Min 0.08
5. Physical Properties
Before Aging: Tensile Strength (Mpa)	Min 14	15 - 21
Before Aging: Ultimate Elongation (%)	Min 500	550 - 630
After Aging: Tensile Strength (Mpa)	Min 14	14 - 22
After Aging: Ultimate Elongation (%)	Min 400	520 - 610
6. Powder Content	Max 2.0 mg/glove	Below 2 mg/glove
7. Biocompatibility	Satisfactory Results (Implied by conclusion)	Primary Dermal Irritation Test, Guinea Pig Sensitization Test (passed)

The performance data of the gloves shown above meet the ASTM D6319-00a Standard and FDA's requirements.

Study Information:

This document is a 510(k) summary for a medical device and provides performance data based on established standards rather than a typical clinical study with patient data. Therefore, some of the requested information (like sample size for test/training sets from patient data, ground truth establishment by experts for medical AI, MRMC studies) is not applicable in this context.

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

The document refers to performance data based on ASTM D6319-00a and FDA 1000ML watertight test.

Sample Size: Not explicitly stated as a single "test set" in terms of patient cases. The ASTM standard specifies how many gloves from a lot must be sampled and tested for each criterion (e.g., AQL for watertightness). The number of individual gloves tested for each property (length, width, thickness, physical properties, powder content) would be determined by the specific sampling plans outlined in ASTM D6319-00a.
Data Provenance: The manufacturing company is stated as ULTRAWIN SDN BHD in Malaysia. The testing was conducted to meet international standards (ASTM) and FDA requirements. Therefore, the data originates from testing conducted by or for the manufacturer, likely in Malaysia or accredited testing facilities. The data is retrospective in the sense that it's a report of tests already performed on manufactured products.

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

Not applicable in the context of glove performance testing against technical standards. The "ground truth" for these tests is defined by the objective measurement methods and specifications within ASTM D6319-00a and FDA regulations. These are quantitative measurements that do not require expert consensus for interpretation in the way clinical diagnostic image interpretation would.

4. Adjudication Method for the Test Set:

Not applicable. The tests are based on objective measurements against specified ranges or thresholds (e.g., minimum length, maximum powder content, AQL for pinholes). There is no "adjudication" in the sense of resolving disagreements between human evaluators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices involving human interpretation (e.g., radiologists reading images) and comparison of performance with and without AI assistance. This document pertains to the physical and barrier properties of examination gloves.

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

Not applicable. This is a physical product, not a software algorithm. The "performance" is the inherent property of the glove itself, measured directly.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is based on objective measurement against established technical standards and regulatory requirements.

ASTM D6319-00a Standard: This standard provides the specific test methods, acceptable ranges, and sampling plans for nitrile examination gloves.
FDA Pinhole Requirements: Specifically, the 1000ml watertight test with an AQL of 2.5 is a regulatory requirement for barrier integrity.
FDA Requirements for Powder Content: Stipulating a maximum of 2.0 mg/glove.
Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization Test.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

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K090828

JUL 2 8 2009

ATTACHMENT H

1.0	SMDA 510 (K) SUMMARY
2.0	Submitter	ULTRAWIN SDN BHDLot 2, Persiaran Perindustrian Kanthan 2,31200 Chemor, Perak, Malaysia.
	Tel	605-2013888
	Fax	605-2011818
	Name of Contact Person	Mr. MAH SIEW HOE
	Official Correspondence
	Date of Summary Prepared
3.0	Name of Device
	Trade Name :	Non-Sterile Powder Free Nitrile Examination Gloves

Synthetic Rubber Examination Gloves Common Name :

Patient Examination Glove, Powder Free Classification Name :

Identification of The Legally Marketed Devices 4.0

Powder Free Nitrile Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Gloves for Mediacal Application.

5.0 Description of the Device

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090828

The Intended Use of Glove 6.0

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

Summary of Performance Data : 7.0

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

TEST	ASTM D 6319-00a	POWDER FREE NITRILE EXAMINATION GLOVES
1. Watertight (1000ml)	Multiple Normal GIAQL =2.5	Pass GIAQL=2.5
2. Length (mm)Size	XSMin 220SMin 220MMin 230LMin 230XL	240 mm minimun for all sizes
3. Palm width (mm)Size	XS70±10S80±10M95±10L111±10XL	73-7883-8893-98103-107
4. Thickness (mm)(Single Layer)
Finger	Min 0.05	Min 0.08
Palm	Min 0.05	Min 0.08
5. Physical Properties
Before AgingTensile Strength (Mpa)	Min 14	15 - 21
Ultimate Elongation (%)	Min 500	550 - 630
After AgingTensile Strength (Mpa)	Min 14	14 - 22
Ultimate Elongation (%)	Min 400	520-610
6. Powder Content	Max 2.0mg/glove	Below 2 mg/glove

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The performance data of the gloves as shown above meet the ASTM D6319-00a 8.0 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirments.
ーズスタート 100 100 100 100 100 100 100 100 100 100 100 100 100 100 1000 1000 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

1090828

The Bicompatibility Test consits of Primary Dermal Irritation Test and Guines Pig 9.0 Sensitization test.
Conclusion 10.0

We conclude that the Mutiple Private Labeled Non-Sterile Powder Free Nitrile Examination Gloves meets :

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 9 8 2009

Mr. Mah Siew Hoe General Manager Ultrawin Sdn Bhd Lot 2, Pesiaran Perindustrian, Kanthan 2, 31200 Chemor, Perak Darul Ridzuan MALAYSIA

Re: K090828

Trade/Device Name: Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 13, 2009 Received: July 16, 2009

Dear Mr. Hoe:

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 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. Hoe

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Cinthia C., Minister for

Susan Runner, D.D.S., M.A. Acting 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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INDICATION FOR USE STATEMENT

ULTRAWIN SDN BHD Applicant:

K090828 510K Number:

Device Name: Powder Free Nitrile Examination Gloves

Indications for Use:

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.

..............................................................................................................................................................................

Prescription Use ... .. No ... ..... Per 21 CFR 801.109

Shuler A. Murphey, MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090828

Over-The-Counter ... ... Yes ... .

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.