BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 19 1999 Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang, Selangor Darul Ehsan MALAYSIA K990542 Re : Brightway™ Brand Nitrile Examination Trade Name: Glove (Powdered) Requlatory Class: I Product Code: LZA February 16, 1999 Dated: Received: February 22, 1999 Dear Mr. Baskaran: 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, Druq, 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, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Baskaran 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 requlation (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}------------------------------------------------ REVISED LABELING : 22" MARCH 1999 510 (K) NO. : K. 990542 910 (R) NO. AN INATION GLOVES (POWDERED) ﻣﻨﻪ ﻳﺴﻤﺢ ﻣﺘﻌﻬﺪ ﺳﺮ ﺗﺨﺴﺎﺳﺎﺕ ﻭ ﺃﻭ ﺭ f 3.0 Indications for use | Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. | |---------------|----------------------------------------------------------| | 510(k) number | : K990542 | | Device name | : Brightway™ Brand Nitrile Examination Gloves (Powdered) | Indications for use: Brightway™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel 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) | | (Division Sign-Off) | |---------------|----------------------------------------| | | Division of General Infection Control, | | | and General Hospital Devices | | 510(k) Number | 990542 | | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <b>X</b> | |------------------------------------------|----|-------------------------------| |------------------------------------------|----|-------------------------------| (Optional Format 1-2-96)