BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

K990283 · Hartalega Sdn Bhd · LZA · Mar 9, 1999 · General Hospital

Device Facts

• Record ID: K990283
• Device Name: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: Expedited Review

Intended Use

The patient 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 devices designed for medical and dental environments. Worn by clinicians, the gloves act as a protective barrier to prevent cross-contamination between the examiner and the patient. The device is manufactured from nitrile material.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use as a standard patient examination glove.

Technological Characteristics

Disposable nitrile examination gloves; powder-free; intended as a protective barrier. No specific ASTM standards or software components described.

Indications for Use

Indicated for use as a disposable medical and dental patient examination glove worn 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1999

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

K990283 Re : Blue Powder-Free Nitrile Examination Trade Name: Gloves Regulatory Class: I Product Code: LZA Dated: January 27, 1999 January 29, 1999 Received:

Dear Mr. Hon

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Hon

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaj.gov/cdr/h/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1988 - 1997 .

510(k) Number (if known) : K990283

Device Name : Blue Powder Free Nitrile Examination Gloves

Indications For Use :

The patient 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

**Over-The-Counter Use**
(Optional Format 1-2-96)

Clim S. Lin

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Division of Dental, Infection Control, and General Hospital Devices 510(k) Number