SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a compass rose with four points. The compass rose is black and white. There are two shapes that look like the number 8 on either side of the compass rose. ## TERANG NUSA Sdn Bhd 510(k) Summary SENSIFLEX Powderfree Latex Examination Glove K990488 ## 510(k) Summary | Submitter Name | Terang Nusa Sdn Bhd | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address | 1, Jalan 8,<br>Pengkalnn Chepa 2 Industrial Zone<br>16100 Kota Bharu,<br>Kelantan, Malaysia. | | Submitter Telephone | +60 9 7735133 | | Submitter Fax | +60 9 7737755 | | Contact Person | LOW, Chin Guan | | Date of preparation | 23 Apr 99 | | Trade Name | SENSIFLEX | | Common Name | Latex Examination Glove | | Classification | Patient Examination Glove | | Legally marketed device to which<br>substantial equivalence is being<br>claimed. | The SENSIFLEX powderfree latex examination<br>glove described in this 510(k) is substantially<br>equivalent to the UNISEAL Gloves, powderfree<br>that is currently marketed. | | Description of device | SENSIFLEX meet the requirement for examination<br>gloves described by the American Standard for<br>Testing and Material ASTM D3578, white in color<br>and non-powdered. Sizes available is from XS --<br>XL | | Intended Use of the device | These examination gloves are to be worn by<br>healthcare workers or similar personnel duringwork to prevent cross contamination between<br>the user and the patient. | | Summary of technological<br>characteristics compared to<br>marketed device | There is no variation in technological<br>characteristics. | | Brief description of non-clinical<br>tests | Test conducted per ASTM D3578, ASTM D512<br>indicates that the product meet the requirements.<br>Primary Skin irritation test ASTM F 719-81<br>Dermal sensitization Test ASTM F 720-81 (86)<br>indicates no sensitization or irritation.<br>Final product is iodine tested for starch free status. | | Brief description of clinical tests | Not carried out | | Conclusion drawn from clinical and<br>non clinical tests | Non-clinical tests and biocompatibility tests<br>indicate device meet all performance and<br>biocompatibility requirements. | | Additional information deemed<br>necessary by the FDA | None | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a company logo and product information. The company name is TERANG NUSA Sdn Bhd. The text also mentions a 510(k) Summary for SENSIFLEX Powderfree Latex Examination Glove. There is also a handwritten number at the top of the image, K990488. {2}------------------------------------------------ Image /page/2/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, which is a symbol often associated with healthcare. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 1999 Mr. Chin-Guan Low Managing Director TERANG NUSA Sdn. Bhd. 1 Jalan 8, Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan, MALAYSIA K990488 Re : SENSIFLEX Powder-Free Latex Examination Trade Name: Glove Regulatory Class: I Product Code: LYY Dated: April 26, 1999 Received: April 30, 1999 Dear Mr. Chin-Guan Low: 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 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 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 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. {3}------------------------------------------------ Page 2 - Mr. Chin-Guan Low 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, Sinal Borges Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a compass rose. The compass rose is black and white. The compass rose has four points, each pointing in a different direction. The compass rose is surrounded by a faint, blurry background. ## TERANG NUSA Sdn Bhd 510(k) Submission SENSIFLEX Powderfree Latex Examination Glove ## 3. Indication for use Statement Submitter 510(k) Number Device Name Trade Name Terang Nusa Sdn Bhd Not available K990488 Powderfree Latex Examination Glove SENSIFILEX Indication for use 1-3 .. ....... These examination gloves are for use by healthcare workers or similar personnel during work to prevent cross contamination or cross infection between the user and the patient. Concurrence of CDHR Office of Device Evaluation (ODE) Clins. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number. | Prescription Use | | |--------------------|--| | Per 21 CFR 801.109 | | FDA-510(k) SENSIFLEX Exam Gloves | OR | Over the counter | |----|------------------| |----|------------------| Page 6 of 22