QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED

{0}------------------------------------------------ . ## QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER - COATED | Submitter's Name : | LATEXX PARTNERS BERHAD | |--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address : | PT 5054, Kamunting Industrial Estate<br>P.O. Box 9<br>34600 Kamunting, Perak,<br>Malaysia. | | Submitter's Phone Number | 605 8915555 | | Submitter 's Fax Number : | 605 8912688 | | Name of Contact Person : | Lim, Chong Eng | | Date of Preparation : | October 11, 1999 | | Name of Device : | QTEXX, NON- CHLORINATED, POWDER<br>FREE NITRILE EXAMINATION GLOVES,<br>POLYMER - COATED | | Trade Name : | Nitrile examination gloves | | Common Name : | Patient Examination Gloves | | Classification Name : | QTEXX, Non -- Chlorinated , Powder Free Nitrile<br>Examination Gloves, Polymer-coated as<br>described in the 510(k) notification are<br>substantially equivalent to the Class 1 patient<br>examination glove 80LZA. It meets all the<br>current specifications listed under the ASTM<br>Specification D 3578 – 99, Standard Specification<br>for Rubber Examination Gloves | | Legally Marketed Device to Which<br>Equivalency is Being Claimed : | | {1}------------------------------------------------ | Description of the Device : | QTEXX, Non - Chlorinated, Powder Free Nitrile<br>Examination Gloves, Polymer-coated meet the<br>current specification listed under the ASTM<br>Specification D 3578 – 99, Standard Specification<br>for Rubber Examination Gloves, They are blue or<br>natural white in colour and are powder free. | |-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use of the Device: | QTEXX, Non - Chlorinated, Powder Free Nitrile<br>Examination Gloves are intended for single use<br>for medical purposes that is worn on the hand of<br>health care and similar personnel to prevent<br>contamination between the health care personnel<br>and the patients. | | Summary of Technological<br>Characteristics Compared to the Predicate<br>Device : | There is no difference in technological<br>characteristics. Gloves are made from nitrile<br>rubber compound and the initial products are<br>powder free nitrile gloves. The powder free nitrile<br>gloves are produced on – line without further<br>chlorination process. No powder is used as mould<br>release agent, but rubber resin coating is used as<br>polymer coating material. | {2}------------------------------------------------ - | Brief Discussion of Nonclinical Tests : | Testing performed as per ASTM D 3578 - 99 and<br>21 CFR 800.20. Gloves meet all the current<br>specifications listed under the ASTM<br>Specification D 3578 -99, Standard Specification<br>for Rubber Examination Gloves for Medical<br>Application.<br><br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation of sensitization.<br><br>Final product is negative for the presence of<br>starch using the USP iodine test. | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this<br>510(k). | | Conclusions Drawn for the Nonclinical<br>and Clinical Tests : | Nonclinical laboratory and animal data indicate<br>that the powder free product meets all<br>performance and bio-compatibility requirements. | | Other Information Deemed Necessary by<br>FDA : | Not applicable. | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 5 1999 Mr. C.E. Lim General Manaqer Latexx Partners Berhad PT 5054, Kamunting Industrial Estate P.O. Box 9, 34600 Kamuntinq Taiping, Perak, Malaysia Re : K992924 Trade Name: Non-Chlorinated, Powder Free Nitrile Exam Gloves, Polymer Coated, Blue Regulatory Class: I Product Code: LZA Dated: October 11, 1999 Received: October 14, 1999 Dear Mr Lim: 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 {4}------------------------------------------------ Page 2 - Mr. Lim 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 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 {5}------------------------------------------------ Attachment 2 ## INDICATIONS FOR USE Applicant LATEXX PARTNERS BERHAD PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA 510(k) Number (if known) K992924 * Device Name Stirt QTEXX, NON- CHLORINATED, NITRILE POWDER FREE EXAMINATION GLOVES POLYMER-COATED Indications For Use : OTEXX. Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED) Concurrence of CDRH Office of Device Evaluation (ODE) AB dr Olivi (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_Kgg 2924 Prescription Use Per 21 CFR 801.109 Over-The-Counter OR