COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 23 1998 Mr. Chee Yong Foo Executive Director Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang, 34750 Matang, Taiping, Perak Darul Ridzuan, MALAYSIA Re: K974424 Trade Name: Comfort Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: March 27, 1998 Received: March 31, 1998 Dear Mr. Chee Yong Foo: 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 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 Regulations, Title 21, Parts 800 to 895. A 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 - Mr. Chee Yong Foo 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) 638-2041 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} Comfort Rubber Gloves Industries Sdn. Bhd. (COMPANY NO.: 260990 U) LOT 821, JALAN MATANG, 34750 MATANG, TAIPING, PERAK DARUL RIDZUAN, MALAYSIA. TEL: 605-8472777 / 8472888 FAX: 605-8476250 Attachment 5 # INDICATIONS FOR USE STATEMENT Applicant: COMFORT RUBBER GLOVES INDUSTRIES SDN BHD 510(k) No.: K974424 Device Name: Comfort Powder-free Latex Examination Glove with Latex (“Powder-free”) 80 LYY Protein Content Labeling Claim (50 micrograms or less) 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.” [Signature] (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number: K974424