PATIENT NITRILE EXAMINATION GLOVES (POWDERED)

{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 body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. JUN 9 - 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Danielle Cottet Quality Controller Wear Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu, North Klang Straits Industrial Area 42000 Port Klang Selangor Darul Ehsan, West Malaysia Re : K992675 Trade Name: Patient Exam Nitrile Powdered Gloves Regulatory Class: I Product Code: LZA Dated: November 25, 1999 Received: December 2, 1999 Dear Ms. Cottet: This letter corrects our substantially equivalent letter of January 20, 2000, regarding the Device Name and the Product Code . 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 cnclosure) 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 goncrols 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 B20) 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 Eederal 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 - Ms. Cottet the Act for devices under the Electronic Product Radiation the Act for devices under the Bicercher Federal laws or regulations. This letter will allow you to begin marketing your device as the FDA This letter will allow you co began notification. The FDA described in your 510(x) piemarke no revice to a legally finding of substantial equivalence of your alagafication for your finding of substantial equivalence of yoursefication for your marketed predicate device resures in a oraceae. device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling If you desire specific advice for gittionally 809.10 for in regulation (21 CFR Part 801 and additionally 809.10 for in regulacion (21 cm Fare 301 and contact the Office of vitro diagnostic devices), prease concastly, for questions on Compliance at (301) 594-4692. Additionally, for quese contact Compliance at (301) 594-4692. Andressdevice, please contact the promotion and advertising of your as 430. Algo, please not the promotion and advertising or (301) 594-4639. Also, please note of the Office of Complance at (1301) 334 1037 - 1057 - 100 - 1 premarket notification - (2) cir circles under the Act may be information on your responsibilities unusi- eurers Assistance obtained from the Division of Small Manufacturers Assist or a obtained from the Division of Smart March (301) 443 6597 or at at its toll-free number (800) 638-2041 acculdade/dsmamain html", at its toll-tree number (800) 636 2041 Of (600) *** its internet address ". its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, William Timothy A. Ulat Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters "WSM" in large, bold font. Below the letters, the words "WEAR SAFE MALAYSIA" are printed in a smaller font. To the right of the letters is a symbol resembling a plus sign or a four-way intersection. The text "SON. BHD P204396-X)" is located to the right of the symbol. The text "Formerly known as WUHRUN SOPLAMED (M) SDN. BHD.)" is printed in a small font below the words "WEAR SAFE MALAYSIA". ## Page 01 of 01 15992675 510 (k) Number (if known) : Device Name : PATIENT EXAMINATION "POWDER" GLOVES , N 14e il C Indications For Use : * A patient Examination Powder 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Presription Use | | OR | Over-The-Counter Use | |----------------------|--|----|--------------------------| | (Per 21 CFR 801.109) | | | (Optional format 1-2-96) | | (Division Sign-Off) | | |----------------------------------------|------------------| | Division of Dental, Infection Control, | | | and General Hospital Devices | | | 510(k) Number | K992687 (K992675 |