SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES

{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 that resembles a stylized caduceus or a representation of the human form. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY | 8 1998 Mr. Foo Khon Pu Smart Glove Corporation Sdn. Bhd. Lot 6487, Bgatu 5 3/4 Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan, MALAYSIA Re : K981348 Trade Name: Smarttex PrePowdered Latex Examination Gloves, (Natural, Blue and Green Colored) Regulatory Class: I Product Code: LYY Dated: April 20, 1998 Received: April 27, 1998 Dear Mr. Foo Khon Pu: 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 qeneral 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 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 {1}------------------------------------------------ Page 2 - Mr. Foo Khon Pu through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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" (21CFR 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/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}------------------------------------------------ Page ੀ। 510(k) NUMBER (IF KNOWN): K 981348 SMARTTEX Pre Powdered Latex Examination Glove DEVICE NAME: Natural. IIE E (AREEN INDICATIONS FOR ાજિમ : This glove is disposable and intended for medical purpose that is worn on the examiner's hand 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<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) | |------------------------------------------|----|--------------------------------------------------| |------------------------------------------|----|--------------------------------------------------| *Chin S. Lim* (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | 510(k) Number | K981348 | |---------------|---------| |---------------|---------|