NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM

K984449 · P.T. Irama Dinamika Latex · LYY · Mar 19, 1999 · General Hospital

Device Facts

• Record ID: K984449
• Device Name: NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
• Applicant: P.T. Irama Dinamika Latex
• Product Code: LYY · General Hospital
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.

Device Story

Disposable patient examination gloves; natural rubber latex; pre-powdered; colored and flavored (Pink/Tutti-Frutti, Blue/Lemon, Green/Peppermint). Used in clinical settings by healthcare providers to provide a barrier against contamination between patient and examiner. Device features low protein content (150 mcg or less of total water extractable protein per gram).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex; pre-powdered; colored and flavored; low protein content (≤150 mcg/g).

Indications for Use

Indicated for use as a disposable device donned on the hands by healthcare personnel 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

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

Re : K984449 Natural Rubber Pre-Powdered Colored and Trade Name: Flavored Patient Examination Gloves (Pink with Tutti-Fruti Flavor, Blue with Lemon Flavor, and Green with Peppermint Flavor) Contains Claim of 150 mcgm or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY December 12, 1998 Dated: Received: January 19, 1999

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

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Page 2 - Mr. Taneja

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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. 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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IRAMA DINAMIKA LATEX PT. Jl. Kapten Pattimura No. 23 / 235, Medan - 20153, Indonesia PHONE : [phone]; 576-502; FAX: 553-389 E- mail : [e-mail]

## Attachment 1

Indication for Use Statement.

INDICATION FOR USE Applicant: PT Irama Dinamika Latex 510(k) Number (if known): 984449 - pending Device Name: Colored and Flavored Pre-powdered Latex Pattent Examination Gloves , P.ok - Tulli-Feath, Brice - River , Gram - pipero - pipermint , Lives , P.
Contains is megro on Tess af Tual City & Charler experiment , States , policings

Indications For Une: A patient examination glove is disposable device intended for mediod purposes that is donned by the user on the hands prevent possible contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ancurrence of CDHR Office of Device Evaluation (ODE)

Prescription Use Or Over-The-Court Per 21 CFR 801.109 (optional Formax 1-2-96)

Baird for Chir

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 19844444