NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE

{0}------------------------------------------------ ### ATTACHMENT 1 K121549 ## 510 (k) Summarv As Required by 21 section 807.92 (c) - Submitter Name: Siam Sempermed Corp., Ltd 1. - 10 Soi 10 Phetkasem Rd. Hatvai 2. Address: Songkhla. Thailand 90110 - 3. Phone: (+66) 74 344 663 - (+66) 74 344 677 4. Fax: Mr. Anan Pruksanusak (Chief Operations Officer) 5. Contract Person: - Date summary prepared: December 5, 2012 6. Official Correspondent: Sempermed USA Inc. 7. - 13900 49th Street North 8. Address: Clearwater, USA , FL 33762 - 727-787-7250 9. Phone: - 727-787-7558 10. Fax: - 11. Contact person: Mr. William E. Harris, III 12. Device Trade or Proprietary Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free 13. Device Common or usual name: Examination glove - 14. Device Classification Name: Polymer patient examination glove - 15. Device Class: Class 1 16. Product Code: LZA 17. Description of the Device: Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue. ### 18. Intended use of the device: This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. ### 19. Predicate devices: - K083755: Non-Sterile, Powder-Free Nitrile Examination Glove with Polymer Coating. Tested for a. use with Chemotherapy Drugs [core glove]. - K024121: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, b. Vitamin E and Protein Claim (50 micrograms or Less) [Aloe & Vitamin E coating]. ### 20. Summary of the Technological Characteristics: Non sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, Vitamin E, Blue is substantially equivalent to the predicate devices. A side-by side comparison of the predicate devices with the subject device is presented in Table 1. {1}------------------------------------------------ Table 1. Side-by-side Comparison of Predicate Devices with Subject Device | Device Description | Predicate 1: K083755 | Predicate 2: K024121 | Subject device | Substantial<br>Equivalence | |--------------------------|--------------------------------|--------------------------------------------------|--------------------------------------|----------------------------| | | Non-Sterile, Powder Free | Non-Sterile, Powder-Free | Non-Sterile, Powder- | | | | Nitrile Blue Examination | Latex Examination | Free Nitrile Examination | | | | Glove with Polymer | Gloves with Polymer | Gloves with Polymer | | | | Coating. Tested for use | Coating, Aloe, Vitamin E | Coating, Aloe and | | | | with Chemotherapy Drugs | and Protein Claim (50 | Vitamin E, Blue | | | | [core glove] | micrograms or Less [aloe<br>& vitamin E coating] | | | | Intended Use | This is a medical device | This is a medical device | This is a medical device | | | | intended for medical | intended for medical | intended for medical | | | | purposes that is worn on | purposes that is worn on | purposes that is worn on | | | | the examiner's hand to | the examiner's hand to | the examiner's hand to | SE | | | prevent contamination | prevent contamination | prevent contamination | | | | between patient and | between patient and | between patient and | | | | examiner | examiner | examiner | | | Device Design | A protective garment that | A protective garment that | A protective garment | | | | covers the hand and wrist | covers the hand and wrist | that covers the hand and | SE | | | with openings for fingers | with openings for fingers | wrist with openings for | | | | and thumb | and thumb | fingers and thumb | | | Primary<br>Compound Used | Nitrile Synthetic latex | Natural Rubber Latex | Nitrile Synthetic Latex | SE | | Single Use | Yes | Yes | Yes | SE | | Ambidextrous | Yes | Yes | Yes | SE | | Sterility | Not applicable | Not applicable | Not applicable | SE | | Biocompatibility | Passes Primary Dermal | Passes Primary Dermal | Passes Primary Dermal | | | | Irritation in Rabbits and | Irritation in Rabbits and | Irritation in Rabbits and | | | | Guinea Pig Closed Patch | Guinea Pig Closed Patch | Guinea Pig Closed Patch | SE | | | Sensitization Test (ISO | Sensitization Test (ISO | Sensitization Test (ISO | | | | 10993-10) | 10993-10) | 10993-10) | | | Dimensions | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE | | Tensile Strength | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE | | Ultimate<br>Elongation | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE | | Freedom from<br>Pinholes | Meets ASTM D5151-6 | Meets ASTM D5151-6 | Meets ASTM D5151-6 | SE | | Residual Powder | Meets ASTM D6124 | Meets ASTM D6124 | Meets ASTM D6124 | SE | | Polymer Coating | Yes | Yes | Yes | SE | | Color | Lavender Blue | Natural | Blue | SE | | Labeling | Includes chemotherapy<br>claim | Includes Aloe and<br>Vitamin E claim | Includes Aloe and<br>Vitamin E claim | SE | | Aloe & Vitamin E | No | Yes | Yes. Same proprietary | SE | ### 19. Conclusion: The physical performance characteristics of the subject device (Non-Sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, and Vitamin E, Blue) is substantially equivalent to predicate K083755 and will perform according to the glove performance standards referenced. Both are manufactured from the same nitrile synthetic latex material using the same production process. The subject device lacks the chemotherapy claim of predicate K083755. Although predicate K024121 is composed of natural rubber latex, it is treated with the same Aloe and Vitamin E coating mixture as the subject device is therefore considered to be substantially equivalent to currently marketed devices. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human figures in profile, stacked on top of each other. The figures are black and have a flowing, abstract design. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### December 27, 2012 Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President and Chief Executive Officer Sempermed USA. Incorporated 13900 49th Street North CLEARWATER FL 33762 Re: K121549 Trade/Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 14, 2012 Received: December 20, 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 devicerelated 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, **Kwame** O. Ulmer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # ATTACHMENT 6 K121549 ## Indications for Use 510(k) Number (if known): K121549 Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free Device Description: Non-sterile, Powder-free Nitrile Examination Glove with Polymer Coating, Aloe, and Vitamin E, Blue **Indications For Use:** Indications For Use: This is a medical device intended for medical purposes that is worn on the examiner's hand 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) Maria Cruz- fisher Digitally signed by Maria Cruz-fisher DN: c=US, o=U.S. Government, ou=H FDA, OI ople, cn=Mari 0.9 2342.19200300.100.1.1=2000576169 Date: 2012.12.27 10:52:14 -0510 (Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices Page 1 of 510(k) Number: