STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

{0}------------------------------------------------ . רכת (KI3707) Page / of 4 APR 2 7 2012 Image /page/0/Picture/3 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a bold, sans-serif font, with the first letter of each word capitalized. # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES (A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92) | Applicant: | Cardinal Health<br>1430 Waukegan Road<br>McGaw Park, IL 60085 | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment<br>Registration Number: | 1423537 | | Regulatory Affairs | | | Contact: | Tatyana Bogdan, RAC | | Telephone: | 847-887-2325 | | Fax: | 847-887-2717 | | E-mail: | tatyana.bogdan-curvin@cardinalhealth.com | | Summary Prepared: | November 13, 2011 | | Trade Name: | Sterile Neoprene Powder-Free Surgical Gloves Tested for Use with<br>Chemotherapy Drugs | | Common Name: | Surgeon's Gloves | | Classification Name: | Surgeon's Gloves | | Classification Panel: | General and Plastic Surgery | | Regulation: | 21 CFR 878.4460 | | Product Code(s): | 79KGO | | Legally marketed<br>device(s) to which<br>equivalence is claimed: | 1. Duraprene SMT Sterile Polyisoprene Powder-Free Surgical Gloves,<br>510(k) K102500, (product code 79KGO).<br>2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves, 510(k)<br>K013302, (product code 79KGO) | | Reason for 510(k)<br>Submission: | Addition of new indications for use: Tested for Use with Chemotherapy<br>Drugs | | Device Description: | The proposed device is a disposable device. It is not made with natural rubber<br>latex. Instead, the gloves are formulated using neoprene synthetic polymer and<br>are coated with nitrile coating. The gloves are manufactured using exact same<br>material used in the currently cleared device, Duraprene SMT gloves, that have | Cardinal Health, Inc. Premarket Notification Submission -- Traditional 510(k). б {1}------------------------------------------------ been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile. #### Intended Use: This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time, 0.01<br>µg/cm²/minute | |-----|-------------------------------------|------------------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 9. | Thiotepa (10 mg/ml) | 82.2 | | 10. | Vincristine sulfate (1 mg/ml) | >240 | Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute. ### Summary of the technological characteristics of the device compared to the predicate device: | Characteristic | Subject Device<br>Sterile Neoprene Powder-<br>Free Surgical Glove<br>w/Chemo Claim | Predicate<br>Sterile Neoprene Powder-<br>Free Surgical Glove<br>(K102500) | Predicate<br>Sterile Neoprene Powder-<br>Free Surgical Glove<br>(K013302) | |-------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------| | Design | Single Use | Single Use | Single Use | | | Sterile | Sterile | Sterile | | | Powder-free | Powder-free | Powder-free | | | Hand Specific | Hand Specific | Hand Specific | | | Independent Thumb | Independent Thumb | Independent Thumb | | | Beaded Cuff | Beaded Cuff | Beaded Cuff | | | Lubricated | Lubricated | Lubricated | | Material<br>Composition | Synthetic Neoprene<br>Polymer coated with<br>Nitrile | Synthetic Neoprene<br>Polymer coated with<br>Nitrile | Synthetic Neoprene<br>Polymer coated with<br>Nitrile | | Intended Use | Powder-Free Surgeon's<br>Glove | Powder-Free Surgeon's<br>Glove | Powder-Free Surgeon's<br>Glove | Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k) 7 {2}------------------------------------------------ | Indications for Use | | Tested for Use with<br>Chemotherapy Drugs | Not Tested | Tested for Use with<br>Chemotherapy Drugs | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimensions &<br>Physical Properties | | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 | | Freedom from<br>Holes | | AQL meets 21CFR 800.20<br>& ASTM D3577<br>requirements | AQL meets 21CFR 800.20<br>& ASTM D3577<br>requirements | AQL meets 21CFR 800.20<br>& ASTM D3577<br>requirements | | Powder Residual | | Meets requirements of<br><=2.0 mg/glove for<br>Powder-Free designation<br>per ASTM D3577 | Meets requirements of<br><=2.0 mg/glove for<br>Powder-Free designation<br>per ASTM D3577 | Meets requirements of<br><=2.0 mg/glove for<br>Powder-Free designation<br>per ASTM D3577 | | PERFORMANCE DATA | | | | | | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | | | | Performance Test Summary-New Device | | | | | | Characteristic | | Standard/Test/FDA<br>Guidance | | Results Summary | | Biocompatibility:<br>Primary Skin Irritation | | ISO 10993-10 | | Gloves are non-irritating. | | Guinea Pig Maximization | | ISO 10993-10 | | Gloves do not display any potential for<br>sensitization. | | Physical Characteristics:<br>Dimensions | | ASTM D3577 | | Meet requirements | | Physical Properties | | ASTM D3577 | | Meet requirements for rubber surgical gloves | | Freedom from Holes | | 21 CFR 800.20 & ASTM<br>D3577 | | Tested in accordance with ASTM D5151 with<br>acceptable results | | Powder Residual | | ASTM D3577 tested using<br>ASTM D6124 standard test<br>method | | Gloves meet powder level requirements for<br>"Powder-Free" designation per ASTM D3577.<br>Results generated values < 2mg of residual<br>powder per glove. | | Chemotherapy Drug<br>Permeation | | ASTM D6978 | | Gloves were tested using ASTM D6978. Under<br>the test conditions prescribed by the test, the<br>minimum normalized breakthrough detection<br>times for each of the chemotherapy drugs tested<br>exceeded the maximum testing time of 240<br>minutes except for Carmustine (BCNU) (3.3<br>mg/ml), which showed permeation time of 0.20<br>minutes, and Thiotepa (10 mg/ml), which<br>showed permeation time of 82.2 minutes. | | Comparative Performance Information Summary | | | | | | Characteristic | | Requirement | New Device | Predicate Device(s) | | Biocompatibility:<br>Primary Skin Irritation | | ISO 10993-1 | Meets requirements | Meets requirements | | Primary Skin Irritation | | ISO 10993-10 | Pass | Pass | | Guinea Pig Maximization | | ISO 10993-10 | Pass | Pass | | Dimensions | | ASTM D3577 | Meets requirements | Meets requirements | | Physical Properties | | ASTM D3577 | Meets requirements | Meets requirements | | Freedom from Holes | | 21CFR 800.20 | Meets requirements | Meets requirements | | Powder Residual | & ASTM D3577<br>ASTM D3577 | Meets requirements | Meets requirements | | | Chemotherapy Drug<br>Permeation | ASTM D6978 | Under the test conditions<br>prescribed by the test, the<br>minimum normalized<br>breakthrough detection<br>times for each of the 10<br>chemotherapy drugs tested<br>exceeded the maximum<br>testing time of 240 minutes<br>except for Carmustine<br>(BCNU) (3.3 mg/ml), which<br>showed permeation time of<br>0.20 minutes, and Thiotepa<br>(10 mg/ml), which showed<br>permeation time of 82.2<br>minutes. | Duraprene gloves cleared<br>under K013302 were tested<br>with 10 chemotherapy drugs<br>in accordance with and met<br>requirements of ASTM F739<br>standard. ASTM F739<br>standard was superseded by<br>ASTM D6978-05. The testing<br>method is the same. The<br>difference is in that the<br>thinnest area of the glove<br>(palm or cuff) is tested and<br>the test results are reported<br>as minimum breakthrough<br>times per ASTM D6978, as<br>opposed to testing a random<br>specimen and reporting the<br>average breakthrough times<br>per ASTM F739. | | | SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE<br>AND/OR OF CLINICAL INFORMATION | | | | | | Clinical data is not required. | | | | | | CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | | | | | Non-clinical data demonstrates that Sterile Neoprene Powder-Free Surgical Gloves Tested for Use with<br>Chemotherapy Drugs meet the technological characteristics of ASTM D3577 standard, and are as safe, as | | | | | Cardinal Health, Inc. ...' Premarket Notification Submission -- Traditional 510(k) {3}------------------------------------------------ effective, and performed as well as the legally marketed devices identified in this summary. Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k) 1 {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing strokes, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062 APR 2 7 2012 Re: K113707 Trade/Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 16, 2012 Received: April 18, 2012 Dear Mr. Devine: 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. {5}------------------------------------------------ #### Page 2 -- Mr. Devine 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 /ucm 115809.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, Za 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 {6}------------------------------------------------ # Indications for Use 510{k) Number (if known): K113705 Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs These powder-free sterile light brown colored surgeon's gloves are a disposable Indications for Use: device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in<br>Minutes, 0.01 µg/cm²/minute | |-----|-------------------------------------|-----------------------------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (20 mg/ml) | >240 | | 6. | Fluorouracil (50.0 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Paclitaxel (6.0 mg/ml) | >240 | | 9. | Thiotepa (10.0 mg/ml) | 82.2 | | 10. | Vincristine Sulfate (1.0 mg/ml) | >240 | Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elisha P. Clavine Will (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: ビリタブのフ Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k) 5