CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES

K991155 · C.V. Anlis Abadi International · LYY · Jun 21, 1999 · General Hospital

Device Facts

• Record ID: K991155
• Device Name: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: C.V. Anlis Abadi International
• Product Code: LYY · General Hospital
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Chlorinated powder-free latex examination gloves; worn on hands by healthcare personnel; serves as protective barrier to prevent cross-contamination between patient and clinician; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; chlorinated; powder-free; examination glove form factor.

Indications for Use

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

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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

Mr. Anwar Firman Managing Director C.V. Anlis Abadi International Jalan Sekip Baru, No.23 Medan INDONESIA

K991155 Re : Chlorinated Powder Free Latex Examination Trade Name: Gloves Requlatory Class: I Product Code: LYY Dated: March 30, 1999 Received: April 6, 1999

Dear Mr. Firman:

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 able beated in the enouse, 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, qood 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. ಗಳ 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Firman

this response to your premarket notification Please note: 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.

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

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Image /page/2/Picture/0 description: The image shows a logo for a company called ANLIS ABADI. Above the company name is a symbol made of squares. Below the company name is the text "C.V. ANLIS ABADI INTERNASIONAL" and "JALAN SEKIP BARU, NO. 23, MEDAN - INDONESIA".

TEL : [phone] / 573068 ~ FAX : [phone]

Attachment H

## Indication For Use Statement

510(K) Number (if known) : K99 || 55 Device Name : Chlorinated Powder Free Latex Examination Gloves Indication For Use :

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

C.V. Anlis Abadi International

Awiay

Aniger A Managing Direc

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Or

Over-The-Counter Use X

(Optimal Format 1-2-96)

Qum Sahm

(Division Sign-O Division of Dental, I 510(k) Numb