ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED

K030335 · Perusahaan Getah Asas Sdn. Bhd. · LZA · Mar 3, 2003 · General Hospital

Device Facts

• Record ID: K030335
• Device Name: ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable nitrile patient examination glove; violet color; powder-free. Worn by healthcare professionals during patient examinations to provide a protective barrier against contamination. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable patient examination glove. Color: Violet. Powder-free. Class I device per 21 CFR 880.6250.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 3 2003

Perusahaan Getah Asas Sdn. Bhd. C/O Mr. James F. Logan Director General Medical Reports Exchange 1301 Defence Highway Gambrills, Maryland 21034

Re: K030335

Trade/Device Name: On-line Powder-free Nitrile Patient Examination Gloves, Violet Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 27, 2003 Received: January 31, 2003

Dear Mr. Logan:

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. Logan

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 vours.

Susan Runner

Susan Runner, DDS, MA Interim 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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Section 3

Page 1 of 1

## 510 (K) Number (if known) : KO3 O335

Device Name

: On-line Powder-free Nitrile Patient Examination Glove, Violet Color

Indications For Use

A 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qum S. Lin

ision of Anesthesiology, General Hospital. Intection Control. Dental De

510(k) Number: K030335

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use -

( Optional Format 1-2-96 )