YULEX LATEX POWDER-FREE EXAM GLOVES

• K Number: K063810
• Device Name: YULEX LATEX POWDER-FREE EXAM GLOVES
• Manufacturer: YULEX CORPORATION
• Date Cleared: 2008-04-18 ( 483 days)
• Product Code: OIG
• Regulation Number: 880.6250

Intended Use

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.

Therapeutic

No
The device is a patient examination glove, intended to provide a barrier against infectious materials and contaminants, not to treat a medical condition.

Diagnostic

No.
The device is a patient examination glove, intended to provide a barrier against infectious materials. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made from guayule natural rubber, clearly described as a disposable hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed in vitro (outside the body).
• Device Description and Intended Use: The description clearly states the device is a "patient examination glove" intended to be "worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants." This is a physical barrier device used on the body, not a device used to test samples from the body.
• Lack of IVD Characteristics: The description does not mention any testing of biological samples, reagents, analytical methods, or any other characteristics associated with in vitro diagnostics.

Therefore, based on the provided information, this device is a medical glove, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OIG

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.
Latex used to manufacture the device meets the requirements for Category 4 Latex defined by ASTM D 1076-06.
Gloves do not contain Hevea antigenic protein.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The technological characteristics of the device, as compared to ASTM or equivalent standards per §807.92(a)(6), are:
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 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.
Performance test data is the same as for §807.92(a)(6) mentioned immediately above under Item [7].
Clinical data not required for gloves.
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].

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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: [phone] Fax: [phone]

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: [phone] Fax: [phone] 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 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.

• [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

2

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 [phone]. 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 [phone] or [phone] 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: [phone] [phone] 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

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