HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED

K980848 · P.T. Irama Dinamika Latex · LYY · Apr 28, 1998 · General Hospital

Device Facts

• Record ID: K980848
• Device Name: HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
• Applicant: P.T. Irama Dinamika Latex
• Product Code: LYY · General Hospital
• Decision Date: Apr 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended is donned by doctors and healthcare workers medical purposes that possible infection/contamination when as protection against examining a patient.

Device Story

Hypoallergenic latex patient examination gloves; disposable; intended for use by healthcare professionals during patient examinations to prevent cross-contamination; provides physical barrier protection; green color; pre-powdered.

Clinical Evidence

No clinical data provided; device is a standard patient examination glove.

Technological Characteristics

Latex material; disposable; pre-powdered; green color; Class I medical device.

Indications for Use

Indicated for use by doctors and healthcare workers as a disposable protective barrier against infection or contamination during patient examinations.

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

APR 28 1998

Mr. Anil Taneja General Manager Pt. Irama Dinamika Latex Jl. Kapten Pattimura No. 23 / 235 Medan 20153 INDONESIA

Re : K980848 Hypoallergenic Latex Patient Exam Gloves-Trade Name: Pre-Powdered, Green Requlatory Class: I Product Code: LYY Dated: February 25, 1998 Received: March 4, 1998

Dear Mr. Taneja:

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 qeneral 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. A ·········· substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Taneja

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 Other qeneral 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tir Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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for

K980848 5 10(k) Number (if known): Pour deres Device Name: HYPOALLERGENICALATEX EXAMINATION GLOVES GREEN Indications For Use: A patient examination glove is a disposable device intended is donned by doctors and healthcare workers medical purposes that possible infection/contamination when as protection against

examining a patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin
(Division Sign-Off)

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

OR

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Optional Format 1-2-96)

Over-The-Counter Use