A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Description

The device is described as a Class I powder-free patient examination glove, made from guayule natural rubber, which meets all of the requirements of ASTM standard D3578-05. A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

AI/ML Overview

The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Dimensions	Meets ASTM D 3578-05	Meets ASTM D 3578-05
Physical Properties	Meets ASTM D 3578-05	Meets ASTM D 3578-05
Freedom from Holes	Meets ASTM D 3578-05	Meets ASTM D 3578-05
Powder-free Residue	Meets ASTM D 3578-05	Meets ASTM D 3578-05
Protein Content	Meets ASTM D 3578-05	Meets ASTM D 3578-05
No Hevea Antigenic Protein	Per method in ASTM D 6499-03	Meets method in ASTM D 6499-03 (stated as "Gloves do not contain Hevea antigenic protein")
Primary Skin Irritation	Passed testing per 16 CFR Part 1500.41, Method of Testing Primary Irritant Substances AND ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity".	Passed testing per 16 CFR Part 1500.41, Method of Testing Primary Irritant Substances AND ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity".
Repeated Patch Dermal Sensitization	Passed testing per ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity", modified to include longer induction exposure period for solid test articles.	Passed testing per ISO 10993-10:2002, "Tests for Irritation and Delayed-Type Hypersensitivity", modified to include longer induction exposure period for solid test articles.
Latex Category	Meets requirements for Category 4 Latex defined by ASTM D 1076-06	Meets requirements for Category 4 Latex defined by ASTM D 1076-06

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

The document does not specify a sample size for the test set regarding the enumerated performance characteristics. The studies are described as meeting specific ASTM and ISO standards, which inherently include sample size requirements within those standards, but these details are not provided in this summary.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given the context of a 510(k) submission to the US FDA, it is implied that the testing was conducted according to international (ASTM, ISO) or US federal standards (16 CFR).

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

This information is not applicable to the device described. The device is a patient examination glove, and its performance is evaluated against engineering, materials, and biocompatibility standards, not through clinical interpretation or expert consensus in the typical sense of a diagnostic device. Ground truth is established through adherence to physical and chemical testing methodologies specified in the standards.

4. Adjudication method for the test set

This information is not applicable to the device. Performance against the specified standards (e.g., ASTM D 3578-05 for physical properties, ASTM D 6499-03 for protein content, ISO 10993-10:2002 for biocompatibility) is determined by direct measurement and observation according to the methods outlined in those standards, not through adjudication by experts.

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

This information is not applicable. The device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is irrelevant to this device.

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

This information is not applicable. The device is a medical glove. There is no algorithm or AI component involved.

7. The type of ground truth used

The ground truth for this device is based on standardized physical, chemical, and biological testing methods. These methods are defined in established and recognized standards such as:

ASTM D 3578-05 (for dimensions, physical properties, freedom from holes, powder-free residue, protein content)
ASTM D 6499-03 (for Hevea antigenic protein content)
16 CFR Part 1500.41 (for primary skin irritation)
ISO 10993-10:2002 (for skin irritation and delayed-type hypersensitivity)
ASTM D 1076-06 (for latex category)

8. The sample size for the training set

This information is not applicable. As the device is a medical glove and not a machine learning model, there is no "training set" in the context of AI. The product undergoes manufacturing quality control and batch testing to ensure consistency with the established performance criteria.

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

This information is not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Yulex. The logo consists of a stylized snowflake-like symbol to the left of the word "YULEX" in bold, sans-serif font. A small trademark symbol is present to the upper right of the word "YULEX".

37860 W. Smith-Enke Road Maricopa, AZ 85238

www.vulex.com Phone: (520) 381-2261 Fax: (520) 568-2556

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Page 1 of 2

[1] 510(k) Summary of Safety and Effectiveness
[2] Yulex Corporation 37860 W Smith-Enke Road Maricopa, AZ 85239, USA Telephone: (520) 381-2261 Fax: (520) 568-2556 Contact: Dr. Katrina Cornish, Senior VP Research and Development Prepared on: May 13, 2008
[3] Trade Name: Yulex® Natural Rubber Examination Gloves Common Name: Examination gloves Classification Name: Patient Examination Glove, powder-free
[4] Substantial equivalence is claimed to the legally marketed device, a Class I powderfree latex patient examination glove, which meets all of the requirements of ASTM standard D3578-05.
[5] The device is described as a Class I powder-free patient examination glove, made from guayule natural rubber, which meets all of the requirements of ASTM standard D3578-05.
[6] A disposable device made from guayule natural rubber. The device may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS, CONTINUED Page 2 of 2

[7] The technological characteristics of the device, as compared to ASTM or equivalent standards per §807.92(a)(6), are:

Characteristic	Standard
Dimensions	Meets ASTM D 3578-05
Physical Properties	Meets ASTM D 3578-05
Freedom from Holes	Meets ASTM D 3578-05
Powder-free Residue	Meets ASTM D 3578-05
Protein Content	Meets ASTM D 3578-05
No Hevea Antigenic Protein	Per method in ASTM D 6499-03
Primary Skin Irritation	Passed testing per 16 CFR Part 1500.41,Method of Testing Primary Irritant Substancesand ISO 10993-10:2002, "Tests for Irritationand Delayed-Type Hypersensitivity".
Repeated Patch DermalSensitization	Passed testing per ISO 10993-10:2002, "Testsfor Irritation and Delayed-TypeHypersensitivity", modified to include longerinduction exposure period for solid test articles.

[8] Performance test data is the same as for §807.92(a)(6) mentioned immediately above under Item [7].
[9] Clinical data not required for gloves.
[10] The device meets all ASTM requirements, biocompatibility requirements, FDA requirements, and labeling claims as indicated by the performance test data listed above under Item [7].
[11]Latex used to manufacture the device meets the requirements for Category 4 Latex defined by ASTM D 1076-06.
[12] Gloves do not contain Hevea antigenic protein.

Dr. Katrina Cornish

May 13, 2008
Date

Premarket Notification 510(k) Number

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three flowing ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2008

Katrina Cornish, Ph.D,FAAAS Senior Vice-President, Research and Development Yulex Corporation 37860 W. Smith-Enke Road Maricopa, Arizona 85238

Re: K063810

Trade/Device Name: Yulex® Natural Rubber Examination Gloves, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: OIG Dated: March 18, 2008 Received: March 20, 2008

Dear Dr. Cornish:

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 - Dr. Cornish

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,

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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37860 W. Smith-Enke Road Maricopa, AZ 85238

www.vulex.com Phone: (520) 381-2261 (520) 568-2556 Fax:

INDICATIONS FOR USE

Applicant:

Yulex Corporation

K063810

510(k) Number:

Device Name:

Yulex® Natural Rubber Examination Gloves, Powder-Free

A disposable device made from guayule natural rubber. The device may Indications for Use: bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Presention Use (Pari 2) CFR 801 Subpart Di

I wer - The - Counter I Ise ANDAOR 171 CFR 80! Subpart C')

(PLEASE DO NOT WRITE BET OW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED:

Солештелсе of CDRH. Office of Device II valuation (ODE)

Shirl A. Murphey

(Division Sign-Ufr) Division of Anesthesiology General Hospital ාction Control, Dental Devices

)(k) Number: K063810

ﻳﺎﺧﺮ ﺍ

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.