MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE

K982877 · Matang Mfg. Sdn. Bhd. · LYY · Nov 30, 1998 · General Hospital

Device Facts

• Record ID: K982877
• Device Name: MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
• Applicant: Matang Mfg. Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

Matang Powder-Free Latex Patient Examination Glove; disposable barrier device worn on hands of healthcare personnel; prevents cross-contamination between patient and clinician; manufactured with protein labeling claim of 50 micrograms or less; intended for general clinical use.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and adherence to manufacturing standards for latex examination gloves.

Technological Characteristics

Latex patient examination glove; powder-free; protein content labeled at 50 micrograms or less; Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the wearer and the patient.

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Matang Manufacturing Sdn. Bhd. C/O Mr. Kok-Kee Hon Official Correspondent 6324 Meeting House Way Alexandria, Virginia 22312-1718

Re : K982877 Trade Name: Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: November 14, 1998 November 16, 1998 Received:

Dear Mr. Kok-Kee 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 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Kok-Kee Hon

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 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" (21CFR 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.fda.gov/cdrh/dsma/dsmama/n.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Appendix 2 Amended 10/23/98

## INDICATIONS FOR USE

Matang Manufacturing Sdn Bhd Applicant :

510 (k) Number (if known) : K982877

. Restring Latex Latex Examination Gloves (1917) Less) Device Name : PROTEIN LABELING CLAIM (50 MICROGR

Indications For Use :

A medical glove is worn on the hand of healthcare and

similar personnel to prevent contamination between

healthcare personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin Si Lin

(Division Sign-Off) (Division Sign of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

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