POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three heads, representing the department's focus on health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. The logo is simple and recognizable, conveying the department's mission and purpose. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 5 2000 Mr. Kuan Kam Hon Manaqing Director Hartalega Sdn. Bhd. 9 Jalan Kuang Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, MALAYSIA Re : K993760 Powdered Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (200 Micrograms or Less) Requlatory Class: I Product Code: LYY Dated: April 21, 2000 Received: April 28, 2000 Dear Mr. Kuan Kam Hon: 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 realour zone 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ಗ 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 requlation 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. Kuan Kam Hon the Act for devices under the Electronic Product Radiation the Act for devices under one acceral laws or regulations. This letter will allow you to begin marketing your device as Ills recei will arrow your your market notification. The FDA described in your 510 x, providence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robals. In a see to proceed to the market. If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (ar en vices), please contact the Office of VILLO dragnosere actroob, Fr. Additionally, for questions on Compilance at (501) 531 ising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarked notification - (ar cir cies under the Art may be Information on your responsible of Small Manufacturers Assistance obtained from the Division of 6mm-2041 or (301) 443-6597 or at at Its Coll-Iree number (600)- 650 East address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATIONS FOR USE ## Applicant : HARTALEGA SDN. BHD. 510(k) Number (if known): K 993760 Device Name : Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 micrograms or less. Indications For Use : The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient. ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED ) Concurrence of CDRH, Office of Device Evaluation (ODE) Clive S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)