LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Huan-Chung Li Vice President Shinemound Enterprise, Incorporated ..... 34 Linnell Circle · ''' ··· · 01821 Billerica, Massachusetts AUG 15 1997 Re : K972104 Powdered Vinyl Synthetic Examination Gloves Trade Name: Requlatory Class: I Product Code: r və qalında və qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalında qalarında qalarında qalarında qalarında qalarında qalarında q Dated: July 25, 1997 Received: August 1, 1997 . . . . . Dear Mr. Huan-Chung Li: 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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 action. In addition, FDA may publish further announcements 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. Huan-Chung Li through 542 of the Act for devices under the Electronic chrough 512 or on the ol 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, K. C. Matoush. y A. Ulatowski Timoth Directbr Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters 'S' and 'M' stacked on top of 'Inc' inside an oval. A horizontal line extends from the right side of the 'M', adding a design element to the logo. The logo appears to be for a company or organization named 'SM Inc'. ## Shinemound Enterprise Inc. 34 LINNELL CIRCLE, BILLERICA, MASSACHUSETTS 01821 Fax (508) 957-7318/436-9983 TEL (508) 436-9980 Attachment 1 1 ## Indication For Use Statement - - - ------------ 510K Number(if known): K972104 Device Name: Powdered Vinyl Synthetic Examination Gloves Indication For Use: A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. Truthfully Yours, ﻢ Piherechagi QS Huan-Chung Li Vice President Shinemound Enterprise, Inc. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | (Division Sign-Off) | | |---------------------------------------------------------------------|------------------------| | Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K972104 | | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | Prescription Use (Per 21 CFR 801.109) | OR | | | Over-The-Counter Use X | (Optional Format 1-2-96)