QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ 1 ### SEP 2 4 1999 510(k) SUMMARY # QTEXX PRE – POWDERED NITRILE EXAMINATION GLOVES | 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 | 605 891 5555 | | Submitter 's Fax Number : | 605 891 2688 | | Name of Contact Person : | Lim, Chong Eng | | Date of Preparation : | September 9, 1999 | | Name of Device :<br>Trade Name :<br>Common Name<br>Classification Name :<br>Legally Marketed Device to Which<br>Equivalency is Being Claimed : | QTEXX PRE - POWDERED NITRILE<br>EXAMINATION GLOVES<br>Nitrile examination gloves<br>Patient Examination Gloves<br>QTEXX Pre - Powdered Nitrile Examination<br>Gloves as described in the 510(k) notification are<br>substantially equivalent to the Class 1 patient<br>examination glove (Nitrile) 80LZA, that<br>meets<br>the current ASTM D 3578 - 99 Standard<br>Specification for Rubber Examination Gloves for<br>Medical Application. | | Description of the Device : | QTEXX Pre - Powdered Nitrile Examination<br>Gloves meet the current specifications listed<br>under the ASTM Specification D 3578 - 99<br>Standard Specification for Rubber Examination<br>Gloves. They are blue or natural white in colour. | | Intended Use of the Device: | QTEXX Pre - Powdered Nitrile Examination<br>Gloves are intended for single use for medical<br>purposes and are worn on the hand of health care<br>and similar personnel to prevent contamination<br>between the health care personnel and the<br>patients. | | Summary of Technological<br>Characteristics Compared to the Predicate<br>Device : | There are no different technological<br>characteristics. Gloves are made from nitrile<br>rubber compound and the initial products are<br>powdered nitrile examination gloves. | | Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578 -99<br>and 21 CFR 800.20. Gloves meet all the current<br>specifications listed under the ASTM<br>Specification D 3578 - 99 Standard Specification<br>for Nitrile Examination Gloves.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation or sensitization.<br>Final product is negative for the test for presence<br>of 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 pre powdered nitrile product meets all<br>performance and biocompatability requirements. | | Other Information Deemed Necessary by<br>FDA : | Not applicable | {1}------------------------------------------------ # K940671 #### Attachment 14 T . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 4 1999 Mr. C.E. Lim General Manger Latexx Partners Bhd. Latexx Farences on Industrial Estate P.O. Box 9, 34600 Kamunting, Taiping, Perak, Malaysia K992671 Re : Qtexx Pre-Powdered Nitrile Examination Trade Name: Gloves (Blue) Regulatory Class: I Product Code: LZA September 9, 1999 Dated: September 14, 1999 Received: Dear Mr. Lim: We have reviewed your Section 510 (k) notification of intent to We have reviewed your section because and we have determined the market the device reference above (for the indications for device is substantially equivalie (iss marketed in interstate use stated in the encrobare, or a che enactment date of the commerce prior to May 20, 1979, or to devices that have been Medical Device Amendments, or as be provisions of the Federal reclassified in accordance trin one four and controle provi Food, Drug, and Cosmetic acc (no, reneval controls provisions market the device, subject to the provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requirements turing practice, labeling, and devices, good manazactashis proposading and adulteration. If your device is classified (see above) into either class II If your device is crabbirsa (solential Approval), it may (Special Controls) of Crabbil controls. Existing major be subject co such additionary device can be found in the Code of regulations arreceing itile 21, Parts 800 to 895. A rederal Regulations, freis Eir ination assumes compliance with Subscancially Cquiring Practice for Medical Devices: General the Good Manufacturing Fracerce 2) and that, through periodic (GMP) regulation (2) Crk Fart our Administration (FDA) will GMP Inspections, che rs. Failure to comply with the GMP verly such assumpcions. Farlatory action. In addition, FDA regulation may rebure in concerning your device in may publish rarener announce: this response to your the rederal hegional. premarket notification submission does not affect any premarket notification babazares. obligation you might have under sections 531 through 542 of {3}------------------------------------------------ Page 2 - Mr. Lim the Act for devices under the Electronic Product Radiation the Act for devices ander Federal laws or regulations. This letter will allow you to begin marketing your device as Info recei will arem for your market notification. The FDA described in your siawn provivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robatsine 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 regulacion (ir devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on compriation and advertising of your device, please contact che Dromotion and 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 Dinector Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Attachment 2 ## INDICATIONS FOR USE | Applicant | LATEXX PARTNERS BERHAD,<br>PT 5054, Kamunting Industrial Estate<br>P.O. Box 9<br>34600 Kamunting, Perak<br>Malaysia | |-----------------------------|---------------------------------------------------------------------------------------------------------------------| | 510(k) Number<br>(if known) | | QTEXX PRE – POWDERED Device Name . NITRILE EXAMINATION GLOVES (BLUE) Indications For Use . • QTEXX Pre - Powdered Nitrile Examination Glove 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) Qlin S. Lin (Division Sign. Off Division of Der olvision and Gener: and Gener 510(k) Nurcher Over-The-Counter OR X