NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest a sense of community and support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 11, 2015 Siam Sempermed Corp., LTD c/o John Calhoun Manager of Regulatory Affairs Sempermed USA, Inc. 13900 49th Street North Clearwater, Florida 33762 Re: K142685 > Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves with Polymer Coating, Aloe, Vitamin E, White and Pink Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 9, 2015 Received: January 12, 2015 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. 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. 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 {1}------------------------------------------------ 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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # ATTACHMENT 6 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K142685 Device Name Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E. White and Pink Indications for Use (Describe) This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## ATTACHMENT 5 ## 510 (k) Summary #### 1.0 Submitter | Company name: | Siam Sempermed Corp., Ltd | |-----------------|-------------------------------------------------------------| | Address: | 10 Soi 10 Phetkasem Rd. Hatyai<br>Songkhla. Thailand 90110 | | Phone: | (+66) 74 344 663 | | Fax: | (+66) 74 344 677 | | Contact Person: | Mr. Anan Pruksanusak (Managing Director) | ### 2.0 Official Correspondent | Company name: | Sempermed USA Inc. | |-----------------------|-------------------------------------------------------| | Address: | 13900 49th Street North<br>Clearwater, USA , FL 33762 | | Phone: | 727-787-7250 | | Fax: | 727-787-7558 | | Contact person: | John V. Calhoun | | 3.0 Preparation Date: | September 11, 2014 | ### 4.0 Identification of Legally Marketed Predicate Device Trade/Proprietary 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 510(k): K121549 Device name: Examination glove {4}------------------------------------------------ Device Classification Name: Patient Examination Gloves (21 CFR 880.6250) Device Class: Class 1 Product Code: LZA Classification Panel: General Hospital (Part 880) #### 5.0 Device description The subject device is a patient examination glove made of a synthetic nitrile latex compound. It is non-sterile, powder-free, with a polymer inner coating of aloe and Vitamin E (per 21 CFR 880.6250, Class I). The device can be either white or pink in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile Examination Gloves identified as Product Code LZA. #### 6.0 Intended Use of Device Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E, White and Pink is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. #### 7.0 Summary of Technological Characteristics of Device and Comparison to Legally Marketed Predicate Device Non-sterile, Powder free Nitrile Examination Glove with Polymer Coating, Aloe, Vitamin E, White and Pink is substantially equivalent to the predicate device, which differs only by color. A side-by side comparison of the predicate device with the subject device is presented in Table 1 on the following pages. {5}------------------------------------------------ ### Table 1. Side-by-side Comparison of Predicate Device with Subject Device | | | Predicate: K121549 | Subject device (K142685) | |--------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Acceptance<br>Criteria/Standards | Non-Sterile, Powder-free<br>Nitrile Examination Glove with<br>Polymer Coating. Aloe and<br>Vitamin E, Blue | Non-Sterile, Powder-free<br>Nitrile Examination Glove with<br>Polymer Coating. Aloe and<br>Vitamin E, White and Pink | | Indications for<br>Use | Medical Glove Guidance<br>Manual | This is a medical device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner | This is a medical device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner | | Device Design | - | A protective garment that<br>covers the hand and wrist with<br>openings for fingers and<br>thumb | A protective garment that<br>covers the hand and wrist with<br>openings for fingers and<br>thumb | | Material | ASTM D6319-10 | Nitrile Synthetic latex | Nitrile Synthetic latex | | Single Use | Medical Glove Guidance<br>Manual | Single use | Single use | | Ambidextrous | Medical Glove Guidance<br>Manual | Ambidextrous | Ambidextrous | | Sterility | Not applicable | Not applicable | Not applicable | | Dimensions | ASTM D6319-10 | Meets ASTM D6319-10<br>-Overall Length:<br>220 mm min (XS, S)<br>230 mm min (M, L, XL)<br>-Width (+/- 10 mm)<br>Size XS:70 mm<br>Size S: 80 mm<br>Size M: 95 mm<br>Size L: 110 mm<br>Size XL: 120 mm<br>-Thickness:<br>Finger: 0.05 mm min<br>Palm: 0.05 mm min | Meets ASTM D6319-10<br>-Overall Length:<br>220 mm min (XS, S)<br>230 mm min (M, L, XL)<br>-Width (+/- 10 mm)<br>Size XS:70 mm<br>Size S: 80 mm<br>Size M: 95 mm<br>Size L: 110 mm<br>Size XL: 120 mm<br>-Thickness:<br>Finger: 0.05 mm min<br>Palm: 0.05 mm min | | Physical<br>Properties | ASTM D6319-10<br>(aging= 70 +/- 2°C for 166 +/-<br>2 hrs; 100 +/- 2° C for 22 +/-<br>0.3 hrs) | Meets ASTM D6319-10<br>(aging= 70 +/- 2°C for 166 +/- 2<br>hrs; 100 +/- 2° C for 22 +/- 0.3<br>hrs)<br>-Tensile Strength:<br>14 MPa min (before aging)<br>14 MPa min (after aging)<br>-Ultimate Elongation:<br>500% min (before aging)<br>400% min (after aging) | Meets ASTM D6319-10<br>(aging= 70 +/- 2°C for 166 +/- 2<br>hrs; 100 +/- 2° C for 22 +/- 0.3<br>hrs)<br>-Tensile Strength:<br>14 MPa min (before aging)<br>14 MPa min (after aging)<br>-Ultimate Elongation:<br>500% min (before aging)<br>400% min (after aging) | | Freedom from<br>Pinholes | ASTM D5151-06 | Meets AQL 2.5, Inspection<br>Level G-1 | Meets AQL 2.5, Inspection<br>Level G-1 | | Residual Powder | ASTM D6124-06 | <2.0 mg/pc | <2.0 mg/pc | | Color | - | Lavender Blue | White and Pink | | Labeling | Medical Glove Guidance Manual | Includes English, French, and Spanish languages | Draft includes English only and lacks other minor elements pending completion of FINAL design; brand name(s) pending | | Biocompatibility | Primary Dermal Irritation in Rabbits and Guinea Pig Closed Patch Sensitization Test (ISO 10993-10) | Under the conditions of these studies, the test article was a non-irritant and non-sensitizer | Under the conditions of these studies, the test article was a non-irritant and non-sensitizer | {6}------------------------------------------------ #### 8.0. Conclusion: The physical performance of the subject device (Nitrile Examination Gloves with Aloe & Vitamin E, Powder-free) is substantially equivalent to predicate K121549 and will perform according to the glove performance and biocompatibility standards referenced. Both are manufactured from the same nitrile synthetic latex material using the same production process. Only the colors differ. Based on the intended use, physical properties, and technological characteristics, the subject device is safe and effective as a legally marketed device.