POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR

{0}------------------------------------------------ ## POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ﯾ | K011791 510(K) SUMMARY | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name : | LATEXX MANUFACTURING SDN. BHD. | | Submitter's Address : | PT 5054, Kamunting Industrial Estate | | | P.O. Box 9, 34600 Taiping, Perak | | AUG 1 2001 | Malaysia | | Submitter's Phone Number | 605 891 1111 | | Submitter 's Fax Number : | 605 891 1088 | | Name of Contact Person : | Lim, Chian Chian | | Date of Preparation : | May 2, 2001 | | Name of Device : | | | Trade Name : | POWDER FREE NITRILE EXAMINATION | | | GLOVES, VIOLET COLOR | | Common Name : | Nitrile examination gloves | | Classification Name : | Patient Examination Gloves | | Description of the Device : | Powder Free Nitrile Examination Gloves, Violet | | | Color meet the current ASTM Standard<br>Specification for Nitrile Examination Gloves for | | | Medical Application. It also meets all the current | | | specifications listed under the ASTM<br>Specification D 6913-00a Standard Specification | | | for Nitrile Examination Gloves. They are violet in | | | colour and are powder free. | | Intended Use of the Device: | Powder Free Nitrile Examination Gloves, Violet | | | Color are intended for single use 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 | | | patients. | | Summary of Technological<br>Characteristics Compared to the Predicate<br>Device: | There is no different technological characteristics.<br>Gloves are made from Nitrile rubber compound<br>and the initial products are powdered Nitrile<br>rubber gloves. These gloves are then further<br>processed into powder free gloves using the<br>existing technology, i.e. washing and then<br>chlorinating the surfaces of the gloves. | | Brief Discussion of Nonclinical Tests: | Testing performed per ASTM D 6913-00a<br>Nitrile Examination Gloves for Medical<br>Application and 21 CFR 800.20. Gloves meet all<br>the current ASTM Standard Specification for<br>Nitrile Examination Gloves for Medical<br>Application.<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>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 biocompatability requirements. | | Other Information Deemed Necessary by<br>FDA: | Not applicable. | {1}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human figures, one behind the other. The figures are connected at the shoulders and appear to be moving forward. AUG 1 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Latexx Partners Bhd. C/O Ms. Christina Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114 Re : K011791 Powder Free Nitrile Examination Trade/Device Name: Gloves, Violet Color Requlation Number: 880.6250 Regulatory Class: I Product Code: LZA Dated: June 8, 2001 Received: June 8, 2001 Dear Ms. Smith: 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 aqainst 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 requlations 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 Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory {3}------------------------------------------------ Page 2 - Ms. Smith 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 ents response or light on you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn aadiation 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 requlation 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 M. Hlatowski 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}------------------------------------------------ ## INDICATIONS FOR USE Applicant LATEXX MANUFACTURING SDN.BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAY SIA 510(k) Number (if known) Koil791 * Device Name : Indications For Use ## POWDER FREE NITRILE EXAMINATION GLOVE, VIOLET COLOR Powder Free Nitrile Examination Glove, Violet Color 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) Clair S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 : 0(k) Number _ Prescription Use Per 21 CFR 801.109 OR Over-The-Counter 12