NON-STERILE, POWDERED LATEX EXAMINATION GLOVE

{0}------------------------------------------------ K681910 # SEP 1 7 2008 # 510 (k) Summary As Required by 21 section 807.92 (c) - 1. Submitter Name: Siam Sempermed Corp., Ltd - 352 Kanjanavanit Road. Pahtong Hatyai Songkhla. Thailand 90230 2. Address: - (+66) 74 291 471 3. Phone: - (+66) 74 471 337 4. Fax: - 5. Contract Person: Mrs. Parawan Paiyasan (Quality System Manager) - 6. Date summary prepared: June 20, 2008 - 7. Official Correspondent: Sempermed USA Inc. - 13900 49th Street North 8. Address: Clearwater, USA , FL 33762 - 727 787 7250 9. Phone: - 727 787 7558 10. Fax: - Mr. William E. Harris 11. Contact person: - 12. Device Trade or Proprietary Name: Non-sterile, powdered latex examination gloves. - 13. Device Common or usual name: Examination glove - 14. Device Classification Name: Glove , Patient Examination , Latex - 15. Description of the Device: Non-Sterile, powdered latex examination gloves. #### 16. Intended use of the device: This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner. ### 17. Summary of The Technological Characteristics of The devices : Non-Sterile, powdered latex examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |-----------------------|----------------------------------------------------------------|--------------------| | Dimensions | ASTM D 3578-05 | Meets | | Physical Properties | ASTM D 3578-05 | Meets | | Freedom from pinholes | ASTM D 3578-05 | Meets | | Powdered Residue | ASTM D 3578-05 | Meets | | Protein Level | ASTM D 3578-05 | Meets | | Biocompatability | Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization | Passes<br>Passes | {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 Non-Sterile, powdered latex examination gloves 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 Latex Examination Glove , Powdered. Indeed , it is equivalent This is better expressed in the tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. | FDA file reference number | 510k number: K895642 | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------| | Attachments inside notification<br>submission file | REFER TO APPENDIX 1 | | TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result<br>REFER TO ADDITIONAL TECHNICAL<br>COMPARATIVE TABLE WITHIN 510K<br>SUBMISSION | | Indications for use | Identical | | Target population | Identical | | Design | Identical | | Materials | Identical | | Performance | Identical | | Sterility | Not applicable | | Biocompatibility | Identical | | Mechanical safety | Identical | | Chemical safety | Identical | | Anatomical sites | Identical | | Human factors | Identical | | Energy used and/or delivered | Identical (Not applicable) | | Compatibility with environment<br>and other devices | Identical | | Where used | Identical | | Standards met | Identical | | Electrical safety | Identical (Not applicable) | | Thermal safety | Identical (Not applicable) | | Radiation safety | Identical (Not applicable) | {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 its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## SEP 1 7 2008 Siam Sempermed Corporation, Limited C/O Mr. John Calhoun Manager of Regulatory Affairs Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762 Re: K081910 Trade/Device Name: Non-Sterile, Powdered Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 26, 2008 Received: August 29, 2008 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. {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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu Lin, Ph.D. Chiu Lin. Ph.D. 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): Device Name: Non-Sterile, Powdered Latex Examination Gloves 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. 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) Shule M. Mupkey 12 --- (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K081990