LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS

{0}------------------------------------------------ K011749 ## AUG 2 2 2001 # Siam Sempermed Corp., Ltd. D 1 10 Moo 8 Kanjanavanit Rd., Hat Yai, Songkhla, Thailand 90230 Tel: 66 074 291 648 to 9 Fax: 66 074 291 650 Page 1 (2) #### 510 (k) SUMMARY 21062001 #### 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 MOO8 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: 80LYY - 4.0 Specification: Latex patient examination glove , Powder Glove (Single side polymer coated) -Class I 80LYY meets all of the requirements of ASTM standard D3578-00 - 5.0 Device Description: Latex Patient Examination glove , Powder Glove (Single side polymer coated) , non sterile 200 micrograms or less of total water extractable protein per gram - 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 Outer Surface : Free from talc (Magnesium silicate) - 8.0 Primary Dermal Irritation in Rabbits Guinea Pig Sensitization (Buehler) : Consumer Product Testing Co. Experiment reference number : T95-0189-1 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 test article is not a sensitizer in guinea pigs, under condition of this test. This document and its contents are confidential. Do not discuss with or give access to people not designated. {1}------------------------------------------------ KO11749 ## Siam Sempermed Corp., Ltd. Page 2 (2) #### 510 (k) SUMMARY 21062001 #### 9.0 QUALITY CHARACTERISTICS | Dimensions | Meet ASTM D 3578-00 | |-----------------------|----------------------------------------------| | Physical Properties | Meet ASTM D 3578-00 | | Protein content | Recommended 200 ug/dm2 in ASTM D 3578-<br>00 | | Freedom from pinholes | Meet ASTM D 3578-00 | | | Meet ASTM D 5151 | 10. Couclusion: Siam Sempermed Latex Patient Examination Glove , 200 micrograms or less of total water extractable protein per gram meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above) P. Quedlingaumbral Dr. POONSUK CHERDKIATGUMCHAI Chief Quality Officer 21062001 ** This document and its contents are confidential. Do not discuss with or give access to people not designated. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 2 2001 Ms. Katie Levinson Product Manager Sempermed USA, Incorporated 30798 US Highway 19 North Palm Harbor, Florida 34684 K011749 Re : Latex Powdered Patient Examination Trade/Device Name: Glove, 200 Micrograms or Less Regulation Number: 880.6250 I Requlatory Class: Product Code: LYY May 24, 2001 Dated: May 31, 2001 Received: Dear Ms. Levinson: 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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. Image /page/2/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country. {3}------------------------------------------------ Page 2 - Ms. Levinson 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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, Patricia Cucesite/Kor 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}------------------------------------------------ | Page | of | |------|----| |------|----| ### INDICATION FOR USE Siam Sempermed Corp. Ltd. Applicant: 510(k) Number (if known): _ K011749 Device Name: Latex Powdered Examination Glove with a Protein Content Labeling Claim of 200 micrograms or less of water extractable protein per glove -- 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) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Olin S. Lahn (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Deyice 510(k) Number -