SENSIFLEX POWDERFREE SURGEON'S GLOVE

{0}------------------------------------------------ JAN 1 3 1999 Image /page/0/Picture/1 description: The image shows a black and white drawing of a compass rose. The compass rose has eight points, with each point being a star shape. There is a faint outline of a shape that looks like a building in the center of the compass rose. The image is simple and clear, with the compass rose being the main focus. ## TERANG NUSA Sdn Bhd 510(k) Summary for SENSIFLEX Powderfree Surgeon's Glove K982957 ## 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 | 15 Aug 98 | | Trade Name | SENSIFLEX | | Common Name | Surgeon's Glove | | Classification | Surgeon's Glove | | Legally marketed device to which<br>substantial equivalence is being<br>claimed. | The SENSIFLEX powderfree surgeon's glove<br>described in this 510(k) is substantially equivalent<br>to the powdered SUR-G GLOV currently being<br>marketed. The difference between the two is the<br>additional manufacturing process that removes the<br>powder from the glove. | | Description of device | SENSIFLEX meet the requirement for surgeon's<br>glove described by the American Standard for<br>Testing and Material ASTM D3577 as Type 1,<br>white in color and non-powdered. Sizes available<br>is from 6 - 9. | | Intended Use of the device | These surgeon's gloves are to be worn by healthcare workers or similar personnel during procedures or in any work to prevent cross contamination between the user and the patient. | | Summary of technological<br>characteristics compared to<br>predicate device | This notification describes the minor changes to the manufacturing process that removes the powder from the device. | | Brief description of non-clinical<br>tests | Test conducted per ASTM D3577, ASTM D512 indicates that the product meet the requirements.<br><br>Primary Skin Irritation in RabbitTest ASTM F 719-81 and Dermal Sensitization Test ASTM F 720 - 81 (86) indicates no sensitization or irritation.<br><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 and bio-compatibility test indicate device meet all performance and bio-compatibility requirements. | | Additional information deemed<br>necessary by the FDA | None | {1}------------------------------------------------ q82957 Image /page/1/Picture/1 description: The image shows a black and white drawing of a compass rose. The compass rose has eight points, with each point being a solid black color. There are some dashed lines around the compass rose, which may be part of the design. The image is simple and clear, with the compass rose being the main focus. ## TERANG NUSA Sdn Bhd 510(k) Summary for SENSIFLEX Powderfree Surgeon's Glove : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, possibly representing health, family, and community. The figures are depicted in a flowing, abstract manner. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 3 1999 Mr. Chin Guan Low Managing Director Terang Nusa Sdn. Bhd. 1. Jalan 8 Pengkalnn Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan, MALAYSIA K982957 Re : Sensiflex Powder-Free Latex Surgeon's Gloves Trade Name: Requlatory Class: I Product Code: KGO November 9, 1998 Dated: November 12, 1998 Received: 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 legally marketed predicate 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (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 requlatory In addition, FDA may publish further announcements action. 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 {3}------------------------------------------------ Page 2 - Mr. Chin Guan Low through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timo II atows 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/Figure/3 description: The image shows a logo with a compass-like symbol on the left and the text "TERANG NUSA Sdn Bhd" on the right. Below the text, it says "510(k) Submission for Surgeon's Gloves". The text is in a simple, bold font, and the overall design is clean and professional. | 510(k) Number | K 982957 | |---------------|--------------------------------------------| | Device Name | SENSIFLEX Powderfree Latex Surgeon's Glove | Indication For Use : A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination Concurrence of CDHR Office of Device Evaluation (ODE) George 1. Weible for Chris S. Zin, Ph D 510(k) Number _ | Prescription Use | | |----------------------|--| | (Per 21 CFR 801.109) | | OR | Over the counter | X | |------------------|---| |------------------|---| ⁽Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices