NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES

{0}------------------------------------------------ 1. . Attachment 13 ## 510(k) SUMMARY MAR 1 5 2007 ## NON-CHLORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | Submitter's Name | MEDTEXX MANUFACTURING SDN. BHD. | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address | PT 4004, Kamunting Industrial Estate<br>34600 Taiping, Perak,<br>Malaysia | | Submitter's Phone Number | 605-891 1111 / 605-891 5555 | | Submitter's Fax Number | 605-891 1088 | | Name of Contact Person | Ooi Loon Seng | | Date of Preparation | | | Name of Device | | | Trade Name | : NON-CHLORINATED, POLYMER COATED,<br>POWDER FREE NATURAL RUBBER LATEX<br>EXAMINATION GLOVES | | Common Name | : Latex Examination Gloves | | Classification Name | : Patient Examination Gloves | | Legally Marketed Device to which Equivalency is<br>Being Claimed | Non-Chlorinated, Polymer Coated, Powder Free<br>Natural Rubber Latex Examination Gloves as<br>described in this 510 K Notification is<br>substantially equivalent to the current Class 1<br>Patient Examination Glove bearing the product<br>code 80LYY ( 21 CFR 880.6250 ). It meets all the<br>current specifications listed under the ASTM<br>Specification D 3578-05, Standard Specification<br>for Rubber Examination Gloves. | | Description of the Device | Non-Chlorinated, Polymer Coated, Powder Free<br>Natural Rubber Latex Examination Glove is<br>substantially equivalent to the Class 1 patient<br>examination glove bearing the product code<br>80LYY ( 21 CFR 880.6250 ). It meets all the<br>current specifications listed under the ASTM<br>Specification D-3578-05, Standard Specification<br>for Rubber Examination Gloves. They are made<br>from natural rubber latex. They are natural white<br>in color and are powder free. | | Intended Use of the Device | Non-Chlorinated, Polymer Coated, Powder Free<br>Natural Rubber Latex Examination Gloves are<br>intended for single use for medical purposes that<br>is worn on the hand of health care and similar<br>personnel to prevent contamination between the<br>health care personnel and the patients. | | Summary of Technological Characteristic<br>Compared to the Predicate Device | There is no different technological characteristic.<br>Gloves are made from natural rubber latex<br>compound and the initial products are low<br>powdered natural rubber latex gloves. These<br>gloves are using the existing technology, i.e.<br>multiple washing and rinsing processes. | | Brief Description of Non-Clinical Tests | Testing were performed per ASTM D 3578-05,<br>Standard Specification for Rubber Examination<br>Gloves and 21 CFR 800.20. Gloves meet all the<br>current ASTM D 3578-05 requirements.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the<br>guinea pig indicate no irritation or sensitization.<br>Final product has been tested negative for the<br>presence of starch using the USP iodine test. | | Brief description of Clinical Tests | No new clinical tests were conducted under this<br>510(k). | | Conclusions Drawn from the Non-Clinical and<br>Clinical Tests | Non-Clinical laboratory and animal based test<br>data indicate that the powder free product meets<br>all performance and biocompatibility<br>requirements. | | Other Information Deemed Necessary by FDA | Not Applicable. | {1}------------------------------------------------ 1 . ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ... {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple, official emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Ooi Loon Seng Regulatory Affairs Manager MEDTEXX Manufacturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate, 34600 Taiping Perak MALAYSIA MAR 1 5 2007 Re: K070072 Trade/Device Name: Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2007 Received: March 5, 2007 Dear Ms. Seng: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Ms. Seng Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Syndie y. Michael Dmd. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {4}------------------------------------------------ Non-Chlorinated Polymer Coated Powder Free Natural Rubber Latex Examination Gloves Attachment 2 ## INDICATIONS FOR USE Applicant MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia. 510(k) Number (if known) 070072 * Device Name NON-CHORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVE Indications For Use Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient. Concurrence of CDRH Office of Device Evaluation (ODE ) | Prescription Use | OR Over-The-Counter <span style="text-decoration: overline;">X</span> | |--------------------|-----------------------------------------------------------------------| | Per 21 CFR 801.109 | | Carrier Company 100 2017