NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE

{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. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing a human profile or a bird in flight. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 1 1999 Dr. A.S. Tan SinetiMed Latex Sdn. Bhd. 118. Loronq Loqam 7 Kamuntaing Raya Industrial Estate, 34600, Taiping, Perak, West Malaysia Re : K983828 NitriKleen-Nitrile Examination Glove Powder-Trade Name: Free Regulatory Class: I Product Code: LZA Dated: December 22, 1998 December 29, 1998 Received: Dear Dr. Tan: 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 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). 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 (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. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 {1}------------------------------------------------ Page 2 - Dr. Tan 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 diaqnostic 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" (21CFR 807.97). Other qeneral 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/dsma/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}------------------------------------------------ ## SINETIMED LATEX SDN. BHD. Lot 118, Jalan Logam 7, Kamunting Raya Industrial Estate 34600 Taiping , Perak Darul Ridzuan, Malaysia. Tel No.: 605-8912777 Fax No .: 605-8912999 ## 3.0 Indications for Use Statement ## INDICATIONS FOR USE SINETIMED LATEX SDN. BHD. Applicant 510(k) Number (if know)* : . | | 983828_ Nitrikkeen Device Name : NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE Indications For Use This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner. ## PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH Office of Device Evaluation (ODE) | Prescription Use | | |--------------------------|---| | OR | | | Over-The-Counter | X | | Per 21 CFR 801.109 | | | (Optional Format 1-2-96) | | * ・・・・ For a new submission, do NOT fill in the 510(k) number blank. Qin S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.