BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE

{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 stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 23 1999 Mr. G. Baskaran Managinq Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah, 42100 Klang Selangor Darul Ehsan MALAYSIA Re: K991752 > Brightway™ Brand Blue Color Latex Trade Name: Examination Glove, Powdered Contains 150 μgm or Less of Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY May 20, 1999 Dated: May 24, 1999 Received: 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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. 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 requlation may result in requlatory action. In {1}------------------------------------------------ Paqe 2 - Mr. Baskaran this response to your premarket notification Please note: 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. 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 requlation 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 A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ ## 3.0 Indications for use | Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | : K991752 | | Device name | : BRIGHTWAYTM Brand Blue Color<br>Latex Examination Gloves, Powdered<br>containing 150 μgm or less of water<br>extractable protein per gram. | Indications for use: BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered containing 150 ugm or less of water extractable protein per I owucied containing 100 pg--------------------------------------------------------------------------------------------------------------------------------------------------grain is a usposable passimilar 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) Prescription Use (Pct 21 CFR 801.109) OR Over-The-Counter Use X (Optional Format 1-2-96) Qiu S. lin (Division Sion-Off) Division of Dental, Infection Control, and General Hospi 510(k) Number