SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Foo Khon Pu SJ Medical Products (M) Sdn Bhd Lot 723, Batu 5.1/2, Jalan... Salan JUN 27-397 Kapar, Klanq Selangor Darul Ehsan Malaysia K971665 Re : Smart - Fit, Powderfree Nitrile Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA Dated: June 5, 1997 Received: June 9, 1997 Dear Mr. Khon Pu: 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) 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 {1}------------------------------------------------ Page 2 - Mr. Khon Pu not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enroagle Siz of on Control provisions, or other Federal laws or requlations. This letter will-al-low you to begin marketing your-device-as--described in your 510(k) premarket notification. The FDA deberined in your tial 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) 594-4618. 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a black and white abstract symbol. The symbol is composed of curved and angular lines, forming a shape that resembles a stylized letter or logo. The design is simple yet distinctive, with a sense of movement and flow. (Company No. 176287 H) | 3.0 | Indication For Use Statement. | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | INDICATIONS FOR USE | | Applicant | SJ MEDICAL PRODUCTS (M) SDN BHD | | 510K (Number) | APPLIED FOR K971665 | | Device Name | Smart-Fit; Nitrile Examination Gloves Powderfree. | | Indication for Use: | This glove is disposable and is intended for medical purposes that is worn on the examiner's hand 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 Dental, Infection Control, and General Hospital Devices 510(k) Number K971665 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X (Option Format 1-2-96) MEDICAL PRODUCTS (M) SDN. BHD. --