BLUE LATEX EXAMINATION GLOVES, POWDER FREE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 9 2001 Ms. Linga Sumarta Marketing Manager Arista Latindo Industrial , Limited P.T. 128 Jalan Kyai Haji Muhammad Mansyur Jakarta Barat, INDONESIA Re: K013320 Trade/Device Name: Blue Latex Examination Gloves, Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 2, 2001 Received: October 5, 2001 Dear Ms. Sumarta: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Hr ), irence of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Ms. Sumarta Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Ulatowski Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ #### ARISTA LATINDO INDUSTRIAL LTD. P GLOVE MANUFACTURER orticle Full KH. MOH MANSYUR 128 1641 1949 1997 1997 1999 1991 1991 1991 1995 1 #### Section No. 3. ## ATTACHMENT #2 ### INDICATIONS FOR USE STATEMENT | Applicant: | PT. ARISTA LATINDO IND. LTD. | |---------------------------|--------------------------------------------| | 510(k) Number (if known): | K013320 * | | Device Name: | Blue Latex Examination Gloves, Powder Free | | Indications For Use: | | A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. # (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 X (Optimal Format 1-2-96) Chis S. Lin (Division Sign-Off) Porision of Dental, Infection Control, : General Hospital Devic is raber _ ISO