HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ T # 510(k) SUMMARY ### MAY 2 8 1929 #### HEALTH + AID ® PREMIUM PRE - POWDERED NITRILE 1991640 EXAMINATION GLOVES | Submitter's Name : | M.R.G. INDUSTRIES SDN. BHD. | |-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address : | PT 4004, Kamunting Industrial Estate, | | | 34600 Taiping Perak | | | Malaysia | | Submitter's Phone Number | 605 891 1111 | | Submitter 's Fax Number : | 605 891 1088 | | Name of Contact Person : | Lim, Chong Eng | | Date of Preparation : | April 27, 1999 | | Name of Device : | | | Trade Name : | HEALTH + AID ® PREMIUM PRE –<br>POWDERED NITRILE EXAMINATION<br>GLOVES | | Common Name | Nitrile examination gloves | | Classification Name : | Patient Examination Gloves | | Legally Marketed Device to Which<br>Equivalency is Being Claimed : | HEALTH + AID ® PREMIUM Pre – Powdered<br>Nitrile Examination Gloves as described in the<br>510(k) notification are substantially equivalent to<br>the Class 1 patient examination glove (Nitrile)<br>80LZA, that meets the current draft ASTM<br>Standard Specification for Nitrile Examination<br>Gloves for Medical Application. It also meets all<br>the current specifications listed under the ASTM<br>Specification D 3578 – 95, Standard Specification<br>for Rubber Examination Gloves, EXCEPT for<br>tensile strength and ultimate elongation. | | Description of the Device : | HEALTH + AID ® PREMIUM Pre - Powdered<br>Nitrile Examination Gloves meet the current<br>specifications listed under the ASTM<br>Specification D 3578 -- 95, Standard Specificatio<br>for Rubber Examination Gloves. They are blu<br>or natural white in colour. | | Intended Use of the Device: | HEALTH + AID ® PREMIUM Pre - Powdered<br>Nitrile Examination Gloves are intended fo<br>single use for medical purposes and are worn o<br>the hand of health care and similar personnel t<br>prevent contamination between the health car<br>personnel and the patients. | | Summary of Technological<br>Characteristics Compared to the Predicate<br>Device : | There are no different technological<br>characteristics. Gloves are made from nitril<br>rubber compound and the initial products an<br>powdered nitrile latex examination gloves. | | Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95<br>and 21 CFR 800.20. Gloves meet all the current<br>specifications listed under the ASTM<br>Specification D 3578 - 95, Standard Specificatio<br>for Nitrile Examination Gloves.<br>Primary skin irritation testing in the rabbit an<br>delayed contact sensitization testing in the guinea<br>pig indicate no irritation or sensitization.<br>Final product is negative for the test for presenc<br>of starch using the USP iodine test. | | Brief Discussion of Clinical Tests : | No new clinical tests were conducted under thi<br>510(k). | | Conclusions Drawn for the Nonclinical<br>and Clinical Tests : | Nonclinical laboratory and animal data indicat<br>that the pre- powdered nitrile product meets a<br>performance and biocompatability requirements. | {1}------------------------------------------------ #### Attachment 15 . . .......................................................................................................................................................................... ు : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : {2}------------------------------------------------ | Other Information Deemed Necessary by | |---------------------------------------| | FDA : | ﻟ ... ... : : . ・ . Not applicable {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 1999 Mr. Chonq Eng Lim General Manaqer MRG Industries Sdn. Bhd. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Kamunting, Taiping, Perak, MALAYSIA Re : K991640 Health + Aid® Premium Nitrile Exam Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: May 5, 1999 Received: May 12, 1999 Dear Mr. Chong Eng 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 Requlations, 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 Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any 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. {4}------------------------------------------------ Page 2 - Mr. Chong Eng Lim This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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" (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, unive SULSAN 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}------------------------------------------------ ## INDICATIONS FOR USE M.R.G. INDUSTRIES SDN. BHD. Applicant PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA 来 Kag1640 510(k) Number : (if known) HEALTH + AID PREMIUM PRE - POWDERED Device Name : NITRILE EXAMINATION GLOVES Indications For Use : · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · HEALTH + AID ° PREMIUM 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) Clim S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Prescription Use Per 21 CFR 801.109 OR Over-The-Counter