POWDERED 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 a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 5 2001 Ms. Selina Segaran Managing Director Seltom Pacific Sdn. Bhd. Lot 25, Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, MALAYSIA K011922 Re : Powdered Latex Examination Gloves Trade/Device Name: Requlation Number: 880.6250 Requlatory Class: I Product Code: LYY Dated: June 15, 2001 Received: June 20, 2001 Dear Ms. Segaran: 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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਸੈ 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 {1}------------------------------------------------ Page 2 - Ms. Segaran comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. action. In addition, TBA may passible gransal Register. Please note: this response to your premarket notification submission does this response to your premarked hove under sections 531 not arress any one act for devices under the Electronic through 542 or the net 10- 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 described in your six (w) quivalence of your device to a legally Finding of bubbeancear of classification for your marketed prodicate abouts 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 regardiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che Dromotion and Compliance at (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Informacion on Jour wision of Small Manufacturers Assistance obcation from one (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 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 1 of 1 ## Pacific Firm : Selfom Son . Bhd. 510 (k) Number (if known) : _ KO 11922 Device Name: Powdered Latex Examination Gloves Without Protein Content Labelling Claim Indications For Use: A patient examination glove is a disposable device intended for medical purposes 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 Use Qain S. lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number . (Optional Format 1-2-96)