POWDER FREE LATEX EXAM GLOVES

K031335 · Tan Sin Lian Industries Sdn. Bhd. · LYY · Oct 16, 2003 · General Hospital

Device Facts

• Record ID: K031335
• Device Name: POWDER FREE LATEX EXAM GLOVES
• Applicant: Tan Sin Lian Industries Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Patient Examination Gloves is a disposable device made of natural rubber latex that 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 potential infectious materials and other contaminants.

Device Story

Disposable natural rubber latex examination glove; worn on hand by healthcare personnel; provides barrier against infectious materials and contaminants; intended for medical examination use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Natural rubber latex material; powder-free; disposable; patient examination glove; Class I device.

Indications for Use

Indicated for use as a disposable medical glove to provide a barrier against infectious materials and contaminants for patients and healthcare personnel.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Tan Sin Lian Industries Sdn. Bhd. C/O Mr. Lee Tan President Wimex, Incorporated 1133 North 4th Street Philadelphia, Pennsylvania 19123

Re: K031335

Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 17, 2003 Received: July 28, 2003

Dear Mr. Tan:

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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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 annlicable, 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 vours.

Susan Ruiner

Chia-Lin, Ph.D.

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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| 510(k) Number (if known): | K031335 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Patient Examination Gloves |
| Indication for Use: | The Powder Free Patient Examination Gloves is a<br>disposable device made of natural rubber latex that may bear a<br>trace amount of glove powder and is intended to be worn on<br>the hand for medical purposes to provide a barrier against<br>potential infectious materials and other contaminants. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Day, Interim Branch
(Division Sign-Off) Chief. 10/16/

Division of Dental, Infection Control and General Hospital Devices

510(k) Number K031335

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use X (Optional Format 1-2-96)