POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES

{0}------------------------------------------------ K013998 ## FEB 1 3 2002 # 510(k) SUMMARY | Submitted For: | SHEEN MORE ENTERPRISE CO., LTD.<br>No. 16 Tou Kung Six Road<br>Tou-Liu Expanded Industrial Park<br>Tou-Liu City, Yun-Lin County<br>Taiwan R.O.C. | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for SHEEN MORE ENTERPRISE<br>CO., LTD.<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone:<br>775-342-2612<br>Fax:<br>775-342-2613<br>E-Mail:<br>Tuckerjan(@aol.com | | Date of Submission: | 29 November 2001 | | Device Name: | POWDER-FREE LAVENDER/PURPLE NITRILE<br>EXAM GLOVES, Class I Device, 80LZA | | Proprietary Name: | (Multiple Labels) Powder-Free Lavender/Purple Nitrile<br>Exam Gloves. | | Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use. | | Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. | | Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. Except for color, it<br>is substantially Equivalent to the device manufactured by<br>Sinochem Ningbo Latex Glove Factory's K980802 glove<br>and Ningbo Yujiang's Lavender/Purple Nitrile Glove<br>(K003563). | EXHIBIT M Page 48 of 49 {1}------------------------------------------------ K013998 510k) Summary page 2. Test Results (Means and/or Successful Results: This device has met or exceeded the following standards and/or tests: ASTM D 3578-00 ASTM D 5712-00 ASTM D 6124-00 ASTM D 5151-00 ASTM F 1671 ASTM F 1383 ASTM F 903 Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Conclusion: This device is substantially equivalent to the devices Approved as K980802 and K003563. EXHIBIT M page 49 of 49 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, stacked on top of each other. The logo is in black and white. Public Health Service FEB 1 3 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sheen More Enterprise Company Limited C/O Janna P. Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550 Re: K013998 Ro13770 Trade/Device Name: Powder-Free Lavender/Purple Nitrile Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 29, 2001 Received: December 4, 2001 Dear Ms. Tucker: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases one the device is substantially equivalent (for the itelered above and have economissore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to may as, as, reclassified in accordance with the provisions of Antendinents, or to devices and have of the Act (Act) that do not require approval of a premarket the redelar Pood, Drug, and Conneasy, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condons provisions of the stration, 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 IT your device is classinod (200 as of ditional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvrasod that 1 Dr. determination that your device complies with other requirements {3}------------------------------------------------ Page 2 - Ms. Tucker of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouctures and securements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rat 807), adolity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadiation 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 110(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 If you desire pochio as a rart 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Comphance wee, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under nother for OF CF ICP of the Division of Small Manufacturers, International and the receiner of over 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 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 {4}------------------------------------------------ ### INDICATIONS FOR USE #### APPLICANT: ### SHEEN MORE ENTERPRISE CO., LTD. #### 510(k) NUMBER: KO1 3998 #### POWDER-FREE LAVENDER/PURPLE DEVICE NAME: NITRILE EXAM GLOVES A patient examination glove is a disposable device intended for medical purposes that is I pations chammanen grow of inger to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) Chis S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev Fifth Number _ EXHIBIT B Page 2 of 49