POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white and appears to be from a scanned document. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 8 1998 Mr. Bob Chan General Manager Perusahaan Getah asas Sdn. Bhd. Lot 754, Jalan Haji Sirat, Off Jalan Kapar, P.O. Box 188, 41720 Klang, Selangor Darul Ehsan, MALAYSIA Re : K980916 Trade Name: Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY May 23, 1998 Dated: Received: June 15, 1998 Dear Mr. Chan: 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ 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 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 not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Chan through 542 of the Act for devices under the Electronic Product Radiation 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 regulation 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", "www Sincerely yours, S. Dutman 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}------------------------------------------------ Section 3 (rev 1) • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Page 1 of 1 | 510 (K) Number (if known) | K980916 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Powder-Free Patient Examination Glove | | Indications For Use | LATEX<br>WITH PROTEIN LABELING CLAIM<br>A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner This glove contains 50 micrograms or less of total water extractable Protein per gram. | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE: IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, :" " Division of Dental, Infection and General Hospital Devices 510(k) Number ામ (){{ ​ໄດ້​ປາກ​ວົງ ກວດ​ກວດ​ລົງ​ການ​ປັກ​ກັບ​ປົ ໄດ້​ແລ້ວ​ໄດ້​ໄດ້​ແລ້ວ​ໃຊ້​ ເຂົ້າ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​​​​​​​​​ ລາວປະເທດ (ລະ (H) > : ເສົາຣ໌ ແຕກຣ໌ເນ : Prescription Use __ __ ___ __________________________________________________________________________________________________________________________________________________ Over-The-Counter Use ( ()ptional Format 1-2-14)