NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

{0}------------------------------------------------ K122 363 SEP 1 0 2012 # 510 (k) Summary As Required by 21 section 807.92 (c) - 1. Submitter Name: Siam Sempermed Corp., Ltd - 10 Soi 10 Phetkasem Rd. Hatvai 2. Address: Songkhla. Thailand 90110 - (+66) 74 344 663 3. Phone: - (+66) 74 344 677 4. Fax: Mr. Anan Pruksanusak (Chief Operations Officer) Contract Person: 5. - Date summary prepared: April 07, 2012 6. 7. Official Correspondent: Sempermed USA Inc. - 13900 49th Street North Address: 8. Clearwater, USA , FL 33762 - 9. Phone: 727 787 7250 - 10. Fax: 727 787 7558 - 11. Contact person: Mr. William E. Harris 12. Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue. 13. Device Common or usual name: Examination glove 14. Device Classification Name: Nitrile Patient Examination Glove (Powder free, Blue color) #### 15. Description of the Device: Non sterile, Powder free Nitrile Examination Glove, Blue. - 16. Intended use of the device: A powder-free 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. #### 17. Summary of The Technological Characteristics of The devices: Non-sterile, Powder free Nitrile Examination Glove, Blue is summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------------------------------------------------|----------------------------------------------------------------|-----------------------| | Dimensions: overall length; width,<br>palm and finger thickness | ASTM D 6319-10 | Meets | | Tensile strength: before and after aging | ASTM D 6319-10 | Meets | | Ultimate elongation: before and after<br>aging | ASTM D 6319-10 | Meets | | Freedom from holes: pinholes AQL 2.5 | ASTM D 6319-10 | Meets | | Powder Free Residue | ASTM D 6319-10 | Meets | | Biocompatability | Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization | Passes<br>Passes | | Dimensions: overall length; width,<br>palm and finger thickness | ASTM D 6319-10 | Meets | {1}------------------------------------------------ ### 18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above. #### 19. Conclusion It can be concluded that the Non sterile, Powder free Nitrile Examination Glove, Blue will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed devices. This device is safe and effective as the predicate device Siam Sempermed Corp., Ltd Nitrile, Examination Glove, Blue, Powder free. Indeed, it is equivalent. This is better expressed in the tabulated comparison as below. A technical comparison process flow chart is offered on the following page. | FDA file reference number of<br>predicate device | 510k number : K083755 (Non-Strile, Powder Free<br>Nitrile Examination Glove, with Polymer Coating.<br>Tested for use with Chemotherapy Drugs | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | TECHNOLOGICAL<br>CHARACTERISTICS | See additional details in main submission, Section<br>4, Subpart H | | Indications for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Similar | | Performance | Identical | | Sterility | Not applicable | | Biocompatibility | Identical | | Mechanical safety | Identical | | Chemical safety | Identical | | Anatomical sites | Identical | | Human factors | Identical | | Energy used and/or delivered | Not applicable | | Compatibility with environment<br>and other devices | Identical | | Where used | Identical | | Standards met | Identical | | Electrical safety | Not applicable | | Dimensional standards | Identical | | Physical properties | Identical | | Thermal safety | Not applicable | | Radiation safety | Not applicable | | Production process | Similar, new device is online chlorinated. See<br>following page for more information | | Labeling | Similar: new device lacks a chemotherapy labeling<br>claim and associated statements | {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002 SEP 10 2012 Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President and Chief Executive Officer Sempermed USA. Incorporated 13900 49TH Street North Clearwater, Florida 33762 - Re: K122363 Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 6. 2012 Received: August 6, 2012 Dear Mr. Harris: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {3}------------------------------------------------ ### Page 2- Mr. Harris 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, For O'Shaughnessy Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): ¡¡ / 22 363 Device Name: Non-sterile, Powder-free Nitrile Examination Glove, Blue Indications For Use: A powder-free 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Amani Abdulla Al-Kathiri of Anestheslology, General Hospital n Control, Dental Devices 510(k) Number, K122363 Page 1 of __