LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)

{0}------------------------------------------------ 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of flowing lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 4 1998 Ms. Ellen Hutapea ·PT. Sarana Indoprotex Jalan Ir. Sutami Km. 07 P.O. Box 214 TNK. Bandar Lampung, 35001 INDONESIA Re : K980605 Latex Patient Examination Gloves (Powder-Trade Name: Free) with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class : I Product Code: LYY December 27, 1997 Dated: February 17, 1998 Received: Dear Ms. Hutapea: 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. ਕਿ 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 {1}------------------------------------------------ Page 2 - Ms. Hutapea 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 (301) 594-4692. 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" (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 (800) 638-20A1 or (301) 443-6597 or at ' its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): ୮୦2 Page ## K 974853 "Powder Fres. I atex examination (Hoves with Protein Content Labeling Claim Davlua Nama ( 50 micrograms or less) Indications For Use; "A pation cxamination glove is a disposable device intended for medical purposes 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) | (Division Sign-Off) | | |----------------------------------------|---------| | Division of Dental, Infection Control, | | | and General Hospital Devices | | | 510(k) Number | K980605 | | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over The Counter Use_X | |------------------------------------------|----|------------------------| |------------------------------------------|----|------------------------| (Optional Format 1-2-96)