POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)

K980572 · Hartalega Sdn Bhd · LYY · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K980572
• Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
• Applicant: Hartalega Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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

Disposable latex examination gloves; worn by medical/dental personnel on hands; function as protective barrier to prevent cross-contamination between patient and examiner. Device features powder-free design with specific protein content labeling claim (50 micrograms or less). Used in clinical or dental settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Feature: Powder-free. Labeling: Protein content claim of 50 micrograms or less.

Indications for Use

Indicated for use as a disposable medical and dental 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Mr. K.H. Kuan Managing Director Hartalega Sdn. Bhd. 9 Jalan Kuang Bulan Taman Kepong, Industrial Estate 52100 Kuala Lumpar Malaysia

Re: K980572 Green Powder-Free Latex Examination Gloves Trade Name: with Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class : T Product Code: LYY February 13, 1998 Dated: February 17, 1998 Received:

## Dear Mr. Kuan:

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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mr. Kuan

concerning your device in the Federal Register. Please note: ebhecriing your aremarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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.fla.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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

Enclosure . _ ... ...

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510(k) Number (if known) : К 9 80 572

Device Name : Powder Free Latex Examination Gloves ( with Protein Content Labeling Claim ) - GREEN 50 MICROGRAMS, OR LESS

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)

Olin S. Lihn

(Division Sign-C Division of Dental, Inf and General Hospit 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

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