RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 6 1999 Ms. Chu Mee Chong Official Correspondent Riverstone Resources Sdn. Bhd. LOT 21909, NO. 5, Lorong Helang Hindik Kepong Baru Industrial Estate 52100 Kuala Lumpue MALAYSIA Re : K990963 Trade Name: RS Nitrilstat Medical Examination Gloves, Powder-Free (Non-Sterile) Regulatory Class: I Product Code: LZA Dated: April 10, 1999 Received: April 20, 1999 Dear Ms. Chu Mee Chong: 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 requlation 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. {1}------------------------------------------------ Page 2 - Ms. Chu Mee Chong 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 (301) 594-4692. Additionally, for questions on comprimise as (on 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely_yours, Susan Kurrrs E 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a pattern of dots that are arranged in a grid-like fashion. The dots are black and the background is white. The dots are more concentrated in the upper right corner of the image and become less concentrated as they move towards the lower left corner. The pattern of dots creates a gradient effect. ## INDICATION FOR USE Applicant 510(k) Number Device Name Riverstone Resources Sdn. Bhd. K990963 RS Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile) A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient. Olin Sihin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number **Over-the-Counter Use** Prescription Use (Per 21 CFR 801.109)