MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle-like emblem. The emblem consists of three overlapping profiles of human heads, suggesting a focus on people and health. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 9 1998 Mr. Bien Long Nien ·Factory Manaqer Perusahaan Intan Emas Sdn. Bhd. Lot P.T. 153 Kawasan Perusahaan Beranang, 43700 Selangor Darul Ehsan, MALAYSIA Re : K982691 Trade Name: Multi-Comfort Powdered Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: July 14, 1998 Received: Auqust 3, 1998 Dear Mr. Bien Long Nien: 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ ## Page 2 - Mr. Bien Long Nien 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}------------------------------------------------ - Indications for Uses: Include the following or equivalent "Indications For Use" page that 3.0 contains the applicants name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indication for use" statement. - * For a new submission, do NOT fill in the 510(k) number blank. ## INDICATIONS FOR USE Applicant: PERUSAHAAN INTAN EMAS SDN. BHD. 510(k) Number (if known): OWDERED MULT - C omfor Device Name: Latex Examination Gloves Willing ROTEN CONTENT LABELLING Claim (200 micro GRAMS OR LESS Indications For Use: > Latex Examination Glove is a disposable medical device intended for medical handling purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the blood, other body fluids, mucous membranes, or non-intact skin of patient. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrent of CDRH Office of Device Evaluation (ODE) Chun S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number Prescription Use Per 21 CFR 801.109 OR Over-The-Counter / (Optional Format 1-2-96)