PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG -5 1999 K.C. Choong Vice President of Manufacturing OmniGrace (Thailand) LTD. 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla Thailand 90250 Re : K991846 Patient Examination Glove, Nitrile, Trade Name: Powdered, Turquoise Regulatory Class: I Product Code: LZA Dated: May 28, 1999 Received: May 28, 1999 Dear K.C. Choong: 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 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 (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. {1}------------------------------------------------ Page 2 - K.C. Choong In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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. 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" (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.qov/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 {2}------------------------------------------------ K991846 OMNIGRACE (THAILAND) LTD. 641 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL: (6674) 439 526 FAX: (6674) 210 600 . ・・ー 14:53 if ﻳﺘﻬﺎﻳﺔ ﺇﻧ : « ﺎ ﺗ なか : : ." . 1 .. ・ : . . ' ・・ :: ਿੰਦਾ ਦਾ ਵਾਲਾ ਸੀ, ਅਤੇ 'ਤੇ : - - な May 1999 Attachment II ## OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Powdered, Turquoise ## INDICATIONS FOR USE STATEMENT Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : Device Name : Omni Flex Nitrile Examination Glove, Powdered, Turquoise ## Indications For Use A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient. Concurrence of CDRH Office of Device Evaluation (ODE) | Prescription Use<br>Per 21 CFR 801.109 | OR | Over-The-Counter <span style="text-decoration: overline;">X</span> | |----------------------------------------|----|--------------------------------------------------------------------| |----------------------------------------|----|--------------------------------------------------------------------| Chin S. Lin (Division Sign-Off) Division of Dental, Infection Control, (5) a Hospital Devices5 : .