NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS

{0}------------------------------------------------ Siam Sempermed Corp., Ltd. D 110 Moo 8 Kanjanavanit Rd., Hat Yai, Songkhla, Thailand 90230 Tel: 66 074 291 648 to 9 Fax: 66 074 291 650 #### 510 (k) SUMMARY 4021220 Page 1 (2) #### 1.0 APPLICANT: Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION., Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650 #### 2.0 CONTACT PERSON Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION., Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650 MR WILLIAM HARRIS SEMPERMED USA Inc. 30798 US Hwy. 19 N Palm Harbor, USA FL 34684 TEL: 727 787 7250 FAX: 727 787 7558 3.0 Device Class: I Product code: 80LZA 4.0 Specification: Nitrile patient examination glove , Powder Free Glove , Blue color , Non sterile Class I 80LZA meets all of the requirements of ASTM standard D6319-00a" 5.0 Device Description: Nitrile Patient Examination glove , Powder free Glove, Blue color non sterile Glove were tested for permeation with Chemotherapy Drugs - 6.0 Intended use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. - 7.0 Surface treatment: Halogenation / Siliconization and extensive washing in water. Outer surface : Free from glove powder - 8.0 Primary Dermal Irritation in Rabbits Guinea Pig Sensitization (Buehler) : Consumer Product Testing Co. Experiment reference number : T99-0171-1 Conclusion : According to Federal Hazardous Substances Act Regulation , (16 CFR 1500.41), and under the conditions of this test , This test article is not a primary dermal irritant This document and its contents are confidential. Do not discuss with or give access to people not designated. {1}------------------------------------------------ ## Siam Sempermed D Corp., Ltd. Page 2 (2) ## 510 (k) SUMMARY ## 9.0 QUALITY CHARACTERISTICS | Dimensions | Meet ASTM D 6319-00ael | |-----------------------|--------------------------------------------| | Physical Properties | Meet ASTM D 6319-00ael | | Residue Powder | Meet ASTM D 6319-00ael | | Freedom from pinholes | Meet ASTM D 6319-00ael<br>Meet ASTM D 5151 | 10. Conclusion: Siam Sempermed Nitrile patient examination glove , Powder Free Glove , Blue color , non sterile meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above) p. Quedlinburg Dr. POONSUK CHERDKIATGUMCHAI Chief Quality Officer Nov 12,2001 This document and its contents are confidential. Do not discuss with or give access to people not designated. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Public Health Service JUN 6 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Siam Sempermed Corporation Limited C/O Mr. John V. Calhoun Sempermed USA, Incorporated 30798 US Highway 19 North Palm Harbor. Florida 34684 Re: K021220 Trade/Device Name: Nitrile Patient Examination Glove Powder-Free (Blue Color) Tested for Use with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 18, 2002 Received: March 22, 2002 Dear Mr. Calhoun: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {3}------------------------------------------------ ### Page 2 - Mr. Calhoun You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sincerely yours, Susan Runser Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE Applicant: Siam Sempermed Corp., Ltd. K 021220 510(k) Number: Device Name: Nitrile Patient Examination Glove Powder-Free (Blue Color) Tested for Use with Chemotherapy Drugs Indications For Use: A Patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880,6250) Gloves to be used for protection against chemotherapy drug exposure during use with chemotherapy drug preparation and administration to patients. Chemotherapy drugs tested are: Amethopterin Hydrate, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubincin Hydrochloride, Etoposide, 5-Flourouracil, Paclitaxel, and Vincristine Sulfate. Qiu S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)