BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

{0}------------------------------------------------ # FORMOSA GLOVE INDUSTRIAL C NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R.C. FAX: 002-886-6-570-0388 TEL: 002-886-6-570-1885~6 SEP 1 0 1999 K992588 Page 1 of 2 ### 510 (k) Summary Date Prepared : July 30, 1999 - 1. Applicant Formosa Glove Industrial Co., Ltd. No 10-8, Ma-Kuo-Li, Matou Town, Tainan Hsien Taiwan Tel: 886-6-570-1885 Fax: 886-6-570-0388 - 2. Contact Person Dr. Tiang S. Chang 1016 Seward Avenue Westfield, N. J. 07090 Tel: 908 233-3571 Fax: 908 233-0925 E-mail: tschang@earthlink.net - 3. Name of Device: | Classification Name | Patient Examination Glove | |---------------------|--------------------------------------------------| | Common Name: | Blue Nitrile Examination Glove, Powder-free | | | Synthetic Powder-free Examination Glove, Nitrile | - 4. Description: Classified by FDA's General and Plastic Device Panel as Class I (21 CFR 880,6250), nitrile patient examination gloves, powder-free, 80 LZA. Meets all requirements of ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application. Also meets all requirement of ASTM D3578, Standard for rubber examination gloves except for ultimate elongation before aging. - న్. Intended Use A disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. {1}------------------------------------------------ ## FORMOSA GLOVE INDUSTRIAL CO., NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R. FAX: 002-886-6-570-0388 TEL: 002-886-6-570-1885~6 510 (k) Summary continue ... Page 2 of 2 #### Comparison to Predicate Device and Equivalence ર્ભ . Non-clinical Performance Date: Applicant device conforms fully to ASTM D5250, Standard for poly(viny) chloride) gloves for medical application. It also meets all requirements of ASTM D3578, Standard for rubber examination gloves, except for ultimate elongation before aging. This device is substantially equivalent to those currently in commercial distribution. Clinical Performance Date: The results of repeated insult patch test (modified Draize test, human study) suggest the applicant device did not induce clinically significant irritation nor have any evidence of induced allergic contact dermatitis in the human subjects. #### 7. Conclusions: This device is safe, effective and substantially equivalent to those currently in commercial distribution. It conforms fully to ASTM D5250, Standard for poly(vinyl chloride) gloves for medical application and applicable 21 CFR requirements for label and marking. It also meets all requirements of ASTM D3578, Standard for rubber examination gloves, except for ultimate elongation before aging. The results of a repeated insult patch test suggest that the device does not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 1999 Formosa Glove Industrial Co., Ltd. Dr. Tiang S. Chang c/o: Official Correspondent 1016 Seward Avenue Westfield, New Jersey 07090 Re : K992588 Blue Nitrile Patient Examination Glove, Trade Name: Powder-free Requlatory Class: I Product Code: LZA Dated: July 30, 1999 Received: August 2, 1999 Dear Dr. Chang: 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, qood 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. Existinq major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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 through 542 of {3}------------------------------------------------ Page 2 - Dr. Chang 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) 594-4690. 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 Other qeneral 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, Timothy A. Ulatowski Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## FORMOSA GLOVE INDUSTRIAL CO., LT NO. 10-8, MA-KUO-LI, MATOU TOWN, TAINAN HSIEN, TAIWAN, R. TEL: 002-886-6-570-1885~6 FAX: 002-886-6-570-0388 ## Indications for Use Formosa Glove Industrial Co., Ltd. Applicant: K992588 510(k) Number (if known): Blue Nitrile Patient Examination Glove, Powder-free Device Name: Indications for Use: 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. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Clim S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number Prescription Use Per 21 CFR 801.109 ાર Over the Counter Use X (Optional Format 1-2-96)