BLUE POWDER FREE NITRILE EXAMINATION GLOVES

K052583 · Hartalega Sdn Bhd · LZA · Jun 14, 2006 · General Hospital

Device Facts

• Record ID: K052583
• Device Name: BLUE POWDER FREE NITRILE EXAMINATION GLOVES
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Blue Powder Free Nitrile Examination Gloves are disposable, single-use protective barriers. Worn by medical and dental professionals during examinations to prevent cross-contamination between patient and examiner. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical and dental settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile material; powder-free; disposable; non-sterile; patient examination glove; Class I device.

Indications for Use

Indicated for use by medical and dental professionals as a protective barrier on the examiner's hand to prevent cross-contamination between patient and examiner.

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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN I 4 2006

Mr. Kuan Kam Hon Managing Director Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur, MALAYSIA

Re: K052583

Trade/Device Name: Blue Powder Free Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 22, 2006 Received: May 25, 2006

Dear Mr. Hon:

-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 -Mr. Hon

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,

Sritte Y. Michael Oms.

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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## Indication For Use

510(k) Number (if known) : Ko52583

Device Name : Blue Powder Free Nitrile Examination Gloves

Indications For Use :

The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

OR Over-The-Counter Use X (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 M. Murphy 15 6/2/06

I of Anasifiesiology, General Hospital, on Control, Dental Devices

4/2/76 K052583