SensiCare PI Surgical Gloves

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 31, 2016 Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060 Re: K152428 Trade/Device Name: SensiCare PI Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: March 3, 2016 Received: March 4, 2016 Dear Jennifer Mason: 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 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 {1}------------------------------------------------ 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 Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152428 Device Name SensiCare PI Surgical Gloves Indications for Use (Describe) The SensiCare PI 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. The following chemicals have been tested with these gloves. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1) Cisplatin 1.0 mg/ml (1,000 ppm) 240 min. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min. Cytarabine 100 mg/ml (100,000 ppm) 240 min. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) 240 min. Doxorubicin Hydrochloride 2.0 mg/ml (2.000 ppm) 240 min. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) 240 min. Fluorouracil 50.0 mg/ml (50,000 ppm) 240 min. Ifosfamide 50.0 mg/ml (50,000 ppm) 240 min. Methotrexate 25 mg/ml (25,000 ppm) 240 min. Mitomycin C 0.5 mg/ml (500 ppm) 240 min. Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min. Paclitaxel (Taxol) 6.0 mg/ml (6.000 ppm) 240 min. Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min. Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is white and appears to be composed of four elongated triangles converging at a central point. A gray bar is visible on the right edge of the image. # SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)] ### Submitter / 510(k) Sponsor Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060 Registration Number: 1417592 ## Contact Person Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com Summary Preparation Date March 31, 2016 Type of 510(k) Submission Traditional ### Device Name / Classification Name of Device: SensiCare PI Surgical Gloves Proprietary Name: SensiCare PI Surgical Gloves Common Name: Surgeon's gloves Classification Name: Surgeon's gloves Product Code: KGO, LZC Regulatory Class: Class I Regulation #: 21 CFR 878.4460 Classification Panel: General Hospital ### Predicate Device Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs K110272 ### Device Description The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with CONFIDENTIAL {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters, stacked on top of a white star-like symbol. The star symbol has four points, with the top and bottom points being longer than the side points. There is a gray rectangle in the upper right corner of the image. polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978. ### Indications for Use: The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by onerating 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. The following chemicals have been tested with these gloves. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes | Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 10.1 min. (10.1, 10.1, 10.1) | |--------------------------------------------------|------------------------------| | Cisplatin 1.0 mg/ml (1,000 ppm) | 240 min. | | Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | 240 min. | | Cytarabine 100 mg/ml (100,000 ppm) | 240 min. | | Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | 240 min. | | Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | 240 min. | | Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | 240 min. | | Fluorouracil 50.0 mg/ml (50,000 ppm) | 240 min. | | Ifosfamide 50.0 mg/ml (50,000 ppm) | 240 min. | | Methotrexate 25 mg/ml (25,000 ppm) | 240 min. | | Mitomycin C 0.5 mg/ml (500 ppm) | 240 min. | | Mitoxantrone 2.0 mg/ml (2,000 ppm) | 240 min. | | Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | 240 min. | | Thiotepa 10.0 mg/ml (10,000 ppm) | 11.6 min. (20.2, 21.5, 11.6) | | Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | 240 min. | Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes. ### Summary of Technological Characteristics The SensiCare PI Surgical Glove is substantially equivalent to the predicate, K110272, Sterile Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs. Both gloves have intended use, same material and the same device performance. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, and to the left of a white star-like symbol with four points. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a distinctive symbol. # TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES | Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Product Name | SensiCare PI Surgical Gloves | Sterile Polyisoprene Powder-<br>Free Surgical Gloves Tested for<br>Use with Chemotherapy Drugs | N/A | | 510(k) Reference | | K110272 | N/A | | Product Owner | Medline Industries, Inc. | Cardinal Health | Different | | Product Code | KGO | KGO | Substantially<br>Equivalent | | Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Substantially<br>Equivalent | | Intended Use | The SensiCare PI surgeon's<br>glove is a disposable device<br>made of synthetic rubber<br>intended to be worn by operating<br>room personnel to protect a<br>surgical wound from<br>contamination. In addition, these<br>gloves were tested for use with<br>chemotherapy drugs in<br>accordance with ASTM D6978<br>Standard Practice for Assessment<br>of Medical Gloves to Permeation<br>by Chemotherapy Drugs.<br>Warning: Do not use with<br>Carmustine and Thiotepa | This powder-free surgeon's<br>glove is a disposable device<br>made of synthetic rubber<br>intended to be worn by operating<br>room personnel to protect a<br>surgical wound from<br>contamination. In addition, these<br>gloves were tested for use with<br>chemotherapy drugs in<br>accordance with ASTM D 6978<br>Standard Practice for Assessment<br>of Medical Gloves to Permeation<br>by Chemotherapy Drugs. | Substantially<br>Equivalent | | Sizes | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | Substantially<br>Equivalent | | Materials | Polyisoprene | Polyisoprene | Substantially<br>Equivalent | | Colorant | Yes - cream colored. Contains a<br>blend of three colorants<br>(naphthos AS red, azo yellow<br>and carbon black) | Yes - cream colored | Substantially<br>Equivalent | | Dimensions -<br>Length | Meets ASTM D 3577<br>270mm min. | Meets ASTM D 3577<br>270mm min. | Substantially<br>Equivalent | | Dimensions - Width | Meets ASTM D 3577<br>5 ½ - 70±6mm<br>6 - 76±6mm<br>6 ½ - 83±6mm<br>7 - 89±6mm<br>7 ½ - 95±6mm | Meets ASTM D 3577<br>5 ½ - 70±6mm<br>6 - 76±6mm<br>6 ½ - 83±6mm<br>7 - 89±6mm<br>7 ½ - 95±6mm | Substantially<br>Equivalent | | | 8 - 102±6mm | 8 - 102±6mm | | | | 8 ½ - 108±6mm | 8 ½ - 108±6mm | | | | 9 - 114±6mm | 9 - 114±6mm | | | Dimensions –<br>Finger Thickness | Meets ASTM D3577<br>0.10mm min | Meets ASTM D3577<br>0.10mm min | Substantially<br>Equivalent | | Dimensions – Palm<br>Thickness | Meets ASTM D3577<br>0.10mm min | Meets ASTM D3577<br>0.10mm min | Substantially<br>Equivalent | | Dimension – Cuff<br>Thickness | Meets ASTM D3577<br>0.10mm min | Meets ASTM D3577<br>0.10mm min | Substantially<br>Equivalent | | Physical Properties | Meets ASTM D3577<br>Before Aging<br>Tensile Strength - 17 MPa min<br>Ultimate Elongation – 650% min<br>Stress at 500% Elongation – 7.0<br>MPa min | Meets ASTM D3577<br>Before Aging<br>Tensile Strength - 17 MPa min<br>Ultimate Elongation – 650% min<br>Stress at 500% Elongation –<br>7MPa min | Substantially<br>Equivalent | | | Meets ASTM 3577<br>After Aging<br>Tensile Strength – 12 MPa min<br>Ultimate Elongation - 490% min | Meets ASTM 3577<br>After Aging<br>Tensile Strength – 12 MPa min<br>Ultimate Elongation – 490% min | Substantially<br>Equivalent | | Freedom from<br>Holes | Meets 21 CFR 800.20 and<br>ASTM D3577 when tested in<br>accordance with ASTM D5151<br>Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 and<br>ASTM D3577 when tested in<br>accordance with ASTM D5151<br>Inspection Level 1, AQL 1.5 | Substantially<br>Equivalent | | Powder or Powder-free | Powder-free | Powder-free | Substantially<br>Equivalent | | Residual Powder | <2mg of residual powder when<br>tested in accordance with ASTM<br>D3577 | <2mg of residual powder when<br>tested in accordance with ASTM<br>D3577 | Substantially<br>Equivalent | | Tested for Use with<br>Chemotherapy<br>Drugs | Yes | Yes | Substantially<br>Equivalent | | Chemotherapy<br>Drugs Tested | | Blenoxane (15mg/ml)>240<br>Busulfan (6mg/ml) >240<br>Carmustine (3.3mg/ml) 0.37<br>Cisplatin (1.0mg/ml) >240<br>Cytarabine (100mg/ml) >240<br>Cyclophosphamide (20mg/ml)<br>>240<br>Dacarbazine (10mg ml) >240<br>Doxorubicin (2.0mg ml) >240<br>Ellence (25mg/ml) >240<br>Etoposide (20mg/ml) ><br>Fludarabine (25mg.ml) >240<br>Fluorouracil (50mg ml) >240 | Similar | | | Carmustine 10.1 | | | | | Cisplatin >240 | | | | | Cytarabine >240 | | | | | Cyclophosphamide >240 | | | | | Dacarbazine >240 | | | | | Doxorubicin >240 | | | | | Etoposide >240 | | | | | Fluorouracil >240 | | | | Ifosfamide >240 | Idarubicin (1mg/ml) >240 | | | | | Ifosfamide (50mg/ml) >240 | | | | | Mechlorethamine HCI (1mg.ml) >240 | | | | Methotrexate >240 | Melphalan (5mg.ml) >240 | | | | Mitoxantrone >240 | Methotrexate (25 mg.ml) >240 | | | | Mitomycin C >240 | Mitoxantrone (2mg.ml) >240 | | | | Paclitaxel >240 | Mitomycin C (0.5mg.ml) >240 | | | | | Paclitaxel (6.0 mg/ml) >240 | | | | | Paraplatin (10mg.ml) >240 | | | | | Rituximab (10mg/ml) >240 | | | | Thiotepa 11.6 | Thiotepa (10mg/ml) 0.44 | | | | | Trisenox (0.1mg.ml) >240 | | | | Vincristine sulfate >240 | Vincristine sulfate (1mg/ml) >240 | | | | Sterile or Non-sterile | Sterile | Sterile | Substantially Equivalent | | Sterilization Method | Gamma 10-6 | Gamma | Substantially Equivalent | | Primary Skin Irritation | Under the conditions of the study (per ISO 10993-10), the device is not an irritant | Meets ISO 10993-10 | Substantially Equivalent | | Sensitization (Guinea Pig Maximization Test) | Under the conditions of the study (per ISO 10993-10), the device is not a sensitizer | Meets ISO 10993-10 | Substantially Equivalent | | Elements Contained on Product Labeling | | | | | • Product Identifier | Yes | Yes | Substantially Equivalent | | • Material | Yes | Yes | Substantially Equivalent | | • Product Characteristics | Yes | Yes | Substantially Equivalent | | • Size | Yes | Yes | Substantially Equivalent | | • Manufacturer Name and Address | Yes | Yes | Substantially Equivalent | | • Single Use Only | Yes | Yes | Substantially Equivalent | | • In Pairs, Left/Right | Yes | Yes | Substantially Equivalent | | • Country of<br>Manufacturing | Yes | Yes | Substantially<br>Equivalent | | • List of<br>Chemotherapy<br>Drugs and<br>Breakthrough<br>Times | Yes | Yes | Substantially<br>Equivalent | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star-like symbol. The star is white and has four points, with the top and bottom points being longer than the side points. The overall design is clean and corporate, suggesting a professional and reliable brand identity. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, placed diagonally across a blue square. A white, stylized starburst shape is behind the text, with its points extending beyond the edges of the square. The overall design is clean and modern. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white symbol that resembles a star or a compass. The symbol is vertically oriented, with its pointed ends extending upwards and downwards. The overall design is clean and professional, conveying a sense of reliability and expertise. ## Summary of Non-Clinical Testing The biocompatibility evaluation for the SensiCare PI Surgical Glove was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The SensiCare PI Surgical Gloves are classified as a surface contacting device with a limited contact duration of less than 24 hours. The following tests were performed to evaluate the biocompatibility of the SensiCare PI Surgical Gloves: - ISO 10993-10: Irritation Intracutaneous reactivity ● - . ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) - Guinea Pig Maximization Test #### Performance Testing (Bench) Permeation testing was conducted on the SensiCare PI Surgical Glove per ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves were tested against fifteen chemotherapy drugs. Physical performance qualities were evaluated per ASTM D3577, Standard Specification for Rubber Surgical Gloves. #### Summary of Clinical Testing This section does not apply. No clinical testing was performed. #### Conclusion In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the SensiCare PI Surgical Glove is as safe and as effective and performs as well as the predicate, Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs (K110272). Therefore, the SensiCare PI Surgical Glove is substantially equivalent to the predicate.