DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE

{0}------------------------------------------------ # UNIVERSAL GLOVES CORPORATIO Shin Ying Industrial Zone No. 10, Shin Jiunn Road, Shin Ying, Tainan, Taiwan, R.O.C. FAX: 886-6-6525105 TEL: 886-6-6525101-4 ## 510(K) SUMMARY Date : December 20, 1997 # K980093 #### Applicant 1. Universal Gloves Corporation No. 10, Shin Jiunn Road, Shin Ying Industrial Zone, Shin Ying, Tainan Hisien, Taiwan, R.O.C. Tel : 886-6-6525101 (4 lines) Fax : 886-6-6525105 #### 2. Contact Person Mr. John Chen No. 10, Shin Jiunn Road, Shin Ying Industrial Zone, Shin Ying, Tainan Hsien, Taiwan, R.O.C. Fax : 886-6-6525105 Tel : 886-6-6525101 (4 lines) #### 3. Device Name Vinyl Patient Examination Gloves, Powder Free #### Device Description 4. (1) Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250 (2) Vinyl Patient Examination Glove, Powder Free, 80LYZ (3) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test. #### ડ. Application The applicant device is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. #### Comparison to Predicate Device ర్. Non-Clinical Performance data Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes. AST Pest Catalog | CASTM DS250-91 | Cast | Appli and and the program of the {1}------------------------------------------------ ## UNIVERSAL GLOVES CORPORATION Shin Ying Industrial Zone No. 10, Shin Jiunn Road, Shin Ying, Tainan, Taiwan, R.O.C. TEL: 886-6-6525101-4 FAX: 886-6-6525105 | Length (mm) | | | |-------------------------|-------------|-------------------------------------------------| | Size S | Min. 230mm | $240\pm5mm$ | | M | Min. 230mm | $240\pm5mm$ | | L | Min. 230mm | $240\pm5mm$ | | XL | Min. 230mm | $240\pm5mm$ | | Width (mm) | | | | Size S | $85\pm5mm$ | $87\pm3mm$ | | M | $95\pm5mm$ | $97\pm3mm$ | | L | $105\pm5mm$ | $107\pm3mm$ | | XL | $115\pm5mm$ | $114\pm3mm$ | | Thickness (mm) | | | | Finger | Min. 0.05mm | Min. 0.08mm | | Palm | Min. 0.08mm | Min. 0.11mm | | Physical Properties | | | | Before Aging | | | | Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa | | Ultimate Elongation (%) | Min. 300% | Min. 300% | | After Aging | | | | Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa | | Ultimate Elongation (%) | Min. 300% | Min. 300% | | FDA Water Leak Test | | Meets AQL 4.0 with a<br>Inspection Level of S-4 | ## Clinical Performance Data The results of Modified Draize Test suggest the applicant device did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects. #### Conclusion 7. The applicant devices conform fully to ASTM I>5250-92 and applicable 21 CFR requirements, and meets FDA 1000ml Water Leak Test. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with 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 MAR - 2 1998 Mr. John Chen Chief Engineer Universal Gloves Corporation 10 Shin Jiunn Road Shin Ying Industrial Zone Shin Ying, Tainan Hsien China (TAIWAN) K980093 Re : Vinyl Patient Examination Gloves, Powder Trade Name: Free Requlatory Class: I LYZ Product Code: February 5, 1998 Dated: February 18, 1998 Received: Dear Mr. Chen: 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 -----requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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: {3}------------------------------------------------ Page 2 - Mr. Chen 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 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) 594-4618. 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) 63&(2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timo ChWA. VIT at c Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ **Page 1 of 1** ### 980093 510(k) Number (if known): Device Name: Vinyl Patient Examination Glove, Powder Free Indications For Use: A patient examination glove is a disposable device intended for medical purpose which is worn on examiner's hand or finger 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) Rauced by Clin --- 51 Olk) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Formal 1-2-96