Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 30, 2018 Medline Industries, Inc. Pauline Maralit Regulatory Affairs Specialist Three Lakes Drive Northfield, IL 60093 Re: K180696 Trade/Device Name: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 8, 2018 Received: March 16, 2018 Dear Pauline Maralit: 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 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); {1}------------------------------------------------ ### Page 2 - Pauline Maralit and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting 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) K180696 #### Device Name Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) #### Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44.0 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Please note that the following drug has extremely low permeation times: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has low permeation times: Thiotepa (10.0 mg/ml) 44.0 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. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, bold letters on a blue background. A white star-like shape is behind the word "MEDLINE". The star shape has four points, with two points extending upwards and downwards, and two points extending to the left and right. **Medline Industries, Inc.** Three Lakes Drive Northfield, IL 60093 # K180696 ## Submitter / 510(k) Sponsor Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 ### Contact Person Pauline Maralit Regulatory Affairs Specialist Phone: 847-949-2283 Email: pmaralit@medline.com Summary Preparation Date April 18, 2018 Type of 510(k) Submission Traditional ### Device Name / Classification Name of Device: Patient Examination Glove (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulation #: 21 CFR 880.6250 ### Predicate Device Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) - K162982 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters stacked vertically. A white abstract shape resembling a stylized star or compass is positioned below the text. The background is a solid blue color, and there is a gray bar on the right side of the image. **Medline Industries, Inc.** Three Lakes Drive Northfield, IL 60093 #### Device Description The Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extrasmall, small, medium, large and extra-large. The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013). #### Indications for Use A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | TABLE 1. Chemotherapy Drugs Tested | | |---------------------------------------|-----------------------------------| | Chemotherapy Drug Tested | Breakthrough Time<br>(in minutes) | | Carmustine (BCNU) 3.3 mg/ml | 13.2 | | Cisplatin 1.0 mg/ml | >240 | | Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 | | Dacarbazine (DTIC)10.0 mg/ml | >240 | | Doxorubicin Hydrochloride 2.0 mg/ml | >240 | | Etoposide (Toposar) 20.0 mg/ml | >240 | | Fluorouracil 50.0 mg/ml | >240 | | Methotrexate 25.0 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Paclitaxel (Taxol) 6.0 mg/ml | >240 | | Thiotepa 10.0 mg/ml | 44.0 | | Vincristine Sulfate 1.0 mg/ml | >240 | Please note that the following drug has extremely low permeation times: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes. Please note that the following drug has low permeation times: Thiotepa (10.0 mg/ml) 44.0 minutes. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters in white against a blue background. To the right of the word "MEDLINE" is a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. # Summary of Technological Characteristics | Device | | | Comparison | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Characteristic | Proposed Device | Predicate Device | Analysis | | Product Name | Medline Green<br>Ambidextrous Powder-Free<br>Nitrile Examination Gloves<br>with Colloidal Oatmeal USP<br>(Tested for use with<br>Chemotherapy Drugs) | Medline Nitrile Powder-Free<br>Examination Glove with<br>Colloidal Oatmeal USP<br>(Tested for Use with<br>Chemotherapy Drugs) | N/A | | 510(k)<br>Reference | K180696 | K162982 | N/A | | Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Same | | Product Code | LZA, LZC | LZA, LZC | Same | | Intended Use | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy<br>drugs as per ASTM D6978-<br>05 (Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy<br>drugs as per ASTM D6978-<br>05 (Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | Same | | Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Materials | Nitrile,<br>Colloidal Oatmeal | Nitrile,<br>Colloidal Oatmeal | Same | | Oatmeal<br>Content | Min. 5mg for all sizes | Min. 5mg for all sizes | Same | | Color | Green | White | Similar | | Sizes | x- small, small, medium,<br>large, x-large | x-small, small, medium,<br>large, x-large | Same | | Dimensions - | Complies with ASTM D6319- | Complies with ASTM D6319- | Same | #### TABLE 2: Comparison of Proposed and Predicate Devices {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The background is a solid dark blue color, providing a strong contrast to the white text and symbol. | Length | 10<br>220mm min. | 10<br>230mm min. | Same | |---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Dimensions -<br>Width | Complies with ASTM D6319-<br>10<br>X-small – 70±10mm<br>Small – 80±10mm<br>Medium – 95±10mm<br>Large – 110±10mm<br>X-large – 120±10mm | Complies with ASTM D6319-<br>10<br>X-small – 70±10mm<br>Small – 80±10mm<br>Medium – 95±10mm<br>Large – 110±10mm<br>X-large – 120±10mm | Same | | Dimensions -<br>Thickness | Complies with ASTM D6319-<br>10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Complies with ASTM D6319-<br>10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Same | | Physical<br>Properties | Complies with ASTM D6319-<br>10 minimum:<br><br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br><br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with ASTM D6319-<br>10 minimum:<br><br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br><br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Same | | Freedom from<br>Holes | Complies with ASTM D6319-<br>10 and ASTM D5151-06 G-1,<br>AQL 1.5 | Complies with ASTM D6319-<br>10 and ASTM D5151-06 G-1,<br>AQL 1.5 | Same | | Powder or<br>Powder-Free | Powder-Free | Powder-Free | Same | | Residual<br>Powder | Complies with ASTM D6319-<br>10 <2mg per glove | Complies with ASTM D6319-<br>10 <2mg per glove | Same | | Contact<br>Durations | Limited <24 hours | Limited <24 hours | Same | | Biocompatibility | AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | Same | | Sterility | Non-sterile | Non-sterile | Same | | Chemotherapy<br>Drugs Tested<br>with Minimum<br>Breakthrough<br>Detection Time<br>as tested per<br>ASTM D6978 | | Blenoxane 15 mg/ml<br>>240 min.<br><br>Bortezomib 1 mg/ml<br>>240 min.<br><br>Busulfan 6 mg/ml<br>>240 min.<br><br>Carmustine (BCNU) 3.3 mg/ml | Different<br><br>Different<br><br>Different<br><br>Similar | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is positioned on the left side of the image, with a small portion of a gray vertical bar visible on the right edge. | 13.2 min. | 11.9 min. | | |-----------------------------------------------------|-------------------------------------------------------|-----------| | | Cetuximab (Erbitux) 2<br>mg/ml<br>>240 min. | Different | | Cisplatin 1.0 mg/ml<br>>240 min. | Cisplatin 1.0 mg.ml<br>>240 min. | Same | | Cyclophosphamide<br>(Cytoxan) 20 mg/ml<br>>240 min. | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml<br>>240 min. | Same | | | Cytarabine 100 mg/ml<br>>240 min. | Different | | Dacarbazine (DTIC)10.0<br>mg/ml<br>>240 min. | Dacarbazine (DTIC)10.0<br>mg/ml<br>>240 min. | Same | | | Daunorubicin 5 mg/ml<br>>240 min. | Different | | | Docetaxel 10.0 mg/ml<br>>240 min. | Different | | Doxorubicin Hydrochloride<br>2.0 mg/ml<br>>240 min. | Doxorubicin Hydrochloride<br>2.0 mg/ml<br>>240 min. | Same | | | Ellence 2 mg/ml<br>>240 min. | Different | | Etoposide (Toposar) 20.0<br>mg/ml<br>>240 min. | Etoposide (Toposar) 20.0<br>mg/ml<br>>240 min. | Same | | | Fludarabine 25 mg/ml<br>>240 min. | Different | | Fluorouracil 50.0 mg/ml<br>>240 min. | Fluorouracil 50.0 mg/ml<br>>240 min. | Same | | | Gemcitabine (Gemzar) 38<br>mg/ml<br>>240 min. | Different | | | Idarubicin 1 mg/ml<br>>240 min. | Different | | | Ifosfamide 50.0 mg/ml<br>>240 min. | Different | | | Irinotecan 20.0 mg/ml<br>>240 min. | Different | | | Mechlorethamine HCl 1.0<br>mg/ml | Different | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white abstract shape that resembles a stylized cross or star. The background is a solid dark blue color. The logo is positioned on the left side of the image, with a small portion of a gray vertical bar visible on the right edge. | | >240 min.<br>Melphalan 5 mg/ml<br>>240 min. | Different | |-----------------------------------------------|-------------------------------------------------|-----------| | Methotrexate 25 mg/ml<br>>240 min. | Methotrexate 25 mg/ml<br>>240 min. | Same | | | Methotrexate 50 mg/ml<br>>240 min. | Different | | Mitomycin C 0.5 mg/ml<br>>240 min. | Mitomycin C 0.5 mg/ml<br>>240 min. | Same | | | Mitoxantrone 2.0 mg/ml<br>>240 min. | Different | | | Oxaliplatin 5 mg/ml<br>>240 min. | Different | | Paclitaxel (Taxol) 6.0 mg/ml<br>>240 min. | Paclitaxel (Taxol) 6.0 mg/ml<br>>240 min. | Same | | | Paraplatin 10 mg/ml<br>>240 min. | Different | | | Pemetrexed Disodium 25<br>mg/ml<br>>240 min. | Different | | | Raltitrexed 0.5 mg/ml<br>>240 min. | Different | | | Rituximab 10 mg/ml<br>>240 min. | Different | | Thiotepa 10.0 mg/ml<br>44.0 min. | Thiotepa 10.0 mg/ml<br>18.6 min. | Similar | | | Trisonex 0.1 mg/ml<br>>240 min. | Different | | | Vidaza (5-Azacytidine) 25<br>mg/ml<br>>240 min. | Different | | | Vinblastine 1 mg/ml<br>>240 min. | Different | | | Vinorelbine 10 mg/ml<br>>240 min. | Different | | Vincristine Sulfate 1.0<br>mg/ml<br>>240 min. | Vincristine Sulfate 1.0<br>mg/ml<br>>240 min. | Same | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters, stacked on top of a white, stylized star shape. The star has four points, with two points extending upwards and two points extending downwards. **Medline Industries, Inc.** Three Lakes Drive Northfield, IL 60093 # Summary of Non-Clinical Testing The biocompatibility evaluation for Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) 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 following tests were performed to evaluate the biocompatibility of Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs): - . ISO 10993-10: Primary Skin Irritation - ISO 10993-10: Dermal Sensitization In lieu of cytotoxicity and acute systemic toxicity testing for the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs), a Certificate of Analysis was provided for the color imparting compound to demonstrate it met its technical specifications and was safe for the intended use. # Performance Testing (Bench) Physical performance qualities of the proposed device were evaluated per ASTM D6319- 10, Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978- 05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs. - ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application - ASTM D 6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves - . ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves {10}------------------------------------------------ Image /page/10/Picture/0 description: The image features the Medline logo, set against a blue square background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white symbol that resembles a compass or a four-pointed star. A small gray rectangle is visible in the upper right corner of the image, partially obscuring the blue background. Northfield. IL 60093 - ASTM D 6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ### Conclusion In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) is as safe and effective for its intended use as the predicate device, the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs), cleared under K162982.