MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE

K033496 · Industrial Clothings, Ltd. · LYY · Mar 9, 2004 · General Hospital

Device Facts

• Record ID: K033496
• Device Name: MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
• Applicant: Industrial Clothings, Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

Device Story

Disposable blue latex examination glove; powder-free; intended for use by healthcare personnel. Worn on hands to provide barrier protection against cross-contamination between patient and examiner. Specifically indicated for handling and preparation of chemotherapeutic agents. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Powder-free. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable patient examination glove to prevent cross-contamination between patient and examiner, and for the handling and/or preparation of chemotherapeutic drugs.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Industrial Clothings, Limited C/O Mr. Albina Bianchi Office Manager MIDAS Safety, Incorporated 255 Duncanmill Road Suite 904 Toronto, Ontario CANADA

Re: K033496

Trade/Device Name: Midas Touch Blue Latex Examination Gloves-Powder free for Chemotherapy Use Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 4, 2003 Received: December 30, 2003

Dcar Mr. Bianchi:

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.

MAR - 9 2004

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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/dsma/dsmamain.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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## Industrial Clothings Limited

(Prime Polymers Division) (Prime Forymers Division)
510(k) submission for Blue Latex Examination Glove – Powder free for Chemotherapy use

## Indications for use statement 3.0

Applicant

: Industrial Clothings Ltd. (Prime Polymers Division)

510(k) number

K033496

Device name

: Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use

Indications for use:

Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

Cusl

Division Sign-Off Division of Anesthesiology. General Hospital. Infection Control

510(k) Number: K033496

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martha I. Lone
Interim Branch Chief
INCB