Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 17, 2024 O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116 ## Re: K242558 Trade/Device Name: Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: November 18, 2024 Received: November 18, 2024 Dear Caitlin Senter: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Allan Guan -S For Bifeng Qian, M.D, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242558 #### Device Name Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid #### Indications for Use (Describe) Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes. CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes. Warning: Not for use with Carmustine, Thiotepa The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: | Fentanyl Citrate Injection (50 mcg/5 ml) | |----------------------------------------------------------------------------| | Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | 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. {4}------------------------------------------------ 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." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through them. To the right of the letters is the company name "Owens & Minor" in a light gray color. ## 510(k) Summary for K242558 ## This summary of 510(k) K242558 is being submitted in accordance with 21 CFR 807.92. | 1. Date Summary was Prepared | December 13, 2024 | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. 510(k) Submitter | O & M Halyard, Inc.<br>9120 Lockwood Blvd.<br>Mechanicsville, Virginia 23116 | | 3. Primary Contact for this 510(k) Submission | Caitlin Senter, MS, RAC<br>Tel: 678-221-7330<br>Email: caitlin.senter@owens-minor.com | | 4. Marketed Common Name | Nitrile Powder-Free Exam Gloves | | 5. Device Submission Trade name and Description | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | | 6. Device Common Name | Medical Exam Gloves | | 7. Device Product Code and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove<br>LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty;<br>OPJ Class I, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs<br>QDO Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove | | 8. Predicate Device | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves (K220373) | | 9. Reference Devices | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929)<br><br>Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633) | | 11. Subject Device Description | The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile,<br>powder-free, textured, ambidextrous, non-sterile patient examination glove<br>that is packed in a cardboard dispenser box. | | | The devices follow consensus standards: | | | ASTM D5151-06 Standard Test Method for Detection of Holes in Medical<br>Gloves | | | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for<br>Medical Applications | | | ASTM D6124-06 Standard Test Method for Residual Powder on Medical<br>Gloves | | | ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical<br>Gloves to Permeation by Chemotherapy Drugs | | | ISO 10993-11: 2017 Biological evaluation of medical devices – Tests for<br>systemic toxicity | | | ISO 10993-10: 2021 Biological evaluation of medical devices -Part 10: Tests<br>for skin sensitization | | | ISO 10993-23: 2021 Biological evaluation of medical devices -Part 23: Tests<br>for irritation | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray color. The font used for the words is a serif font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray. | 12. Indications for Use for<br>Halyard Black Nitrile Powder-<br>Free Exam Gloves with Textured<br>Grip Technology, Tested for Use<br>with Chemotherapy Drugs,<br>Fentanyl Citrate, Simulated<br>Gastric Acid and Fentanyl in<br>Simulated Gastric Acid | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip<br>Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,<br>Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable<br>devices intended for medical purposes that is worn on the examiner's hand to<br>prevent contamination between patient and examiner. | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: | Cisplatin | 1 mg/ml | |---------------------|----------| | Cyclophosphamide | 20 mg/ml | | Dacarbazine | 10 mg/ml | | Doxorubicin HCl | 2 mg/ml | | Etoposide | 20 mg/ml | | Fluorouracil | 50 mg/ml | | Ifosfamide | 50 mg/ml | | Mitoxantrone HCl | 2 mg/ml | | Paclitaxel | 6 mg/ml | | Vincristine Sulfate | 1 mg/ml | CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: | Carmustine | 3.3 mg/ml: Do not use | |------------|-----------------------| |------------|-----------------------| CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: | Thiotepa | 10 mg/ml: Do not use | |----------|----------------------| |----------|----------------------| Warning: Not for use with Carmustine, Thiotepa The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: | Fentanyl Citrate Injection | (50 mcg/5 ml) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |----------------------------|------------------------------------------------------------------------------------------| |----------------------------|------------------------------------------------------------------------------------------| {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for Owens & Minor. The logo consists of two parts: a maroon-colored symbol on the left and the company name "Owens & Minor" in gray on the right. The symbol on the left appears to be a stylized representation of the letters "OM" with horizontal lines running through it. | 13. | Subject Device<br>Halyard Black<br>Nitrile Powder-Free<br>Exam Gloves with<br>Textured Grip | Predicate Device<br>K220373 | Reference Device<br>K213929 | Reference Device<br>K200633 | Comparison | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | FDA Product<br>Code | LZA, LZC, OPJ, QDO | LZA, OPJ, QDO | LZA, OPJ, QDO | LZA, QDO, LZC | Similar | | FDA<br>Classification | Class I | Class I | Class I | Class I | Same | | Regulation<br>Number | 880.6250 | 880.6250 | 880.6250 | 880.6250 | Same | | Common Name | Non-Powdered<br>Patient Examination<br>Glove | Non-Powdered<br>Patient<br>Examination Glove | Non-Powdered<br>Patient<br>Examination Glove | Non-Powdered<br>Patient<br>Examination Glove | Same | | Device Trade<br>Name | Halyard Black Nitrile<br>Powder-Free Exam<br>Gloves with<br>Textured Grip<br>Technology, Tested<br>for Use with<br>Chemotherapy<br>Drugs, Fentanyl<br>Citrate, Simulated<br>Gastric Acid and<br>Fentanyl in<br>Simulated Gastric<br>Acid | Get-A-<br>Grip/Rescue-Grip,<br>Nitrile Two Toned<br>Black/Green,<br>Diamond Grip<br>Technology,<br>Powder-Free, Non-<br>sterile,<br>Ambidextrous,<br>Beaded Cuff,<br>Medical Grade<br>Exam Gloves | Halyard Purple<br>Nitrile, Powder-<br>Free Exam Gloves | Halyard Black-Fire<br>Powder-Free<br>Nitrile Exam Glove | Similar | | Intended Use | The device is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>These gloves were<br>tested for use with<br>chemotherapy<br>drugs, fentanyl<br>citrate, simulated<br>gastric acid and<br>fentanyl in<br>simulated gastric<br>acid as listed on the<br>label. | A Nitrile powder<br>free exam glove is<br>a disposable<br>device, worn on<br>the hand or finger<br>to prevent<br>contamination<br>between examiner<br>and patient or<br>victim.<br>This specialty<br>glove has also<br>been tested for<br>use with the<br>Opioid drugs<br>Fentanyl citrate,<br>Heroin, and both<br>Opioids in<br>simulated Gastric<br>Acid as listed on<br>the label. | The devices are<br>disposable devices<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand to prevent<br>contamination<br>between patient<br>and examiner.<br>These gloves were<br>tested for use<br>with<br>chemotherapy<br>drugs, fentanyl<br>citrate, simulated<br>gastric acid<br>fluid/fentanyl<br>citrate injection<br>mix 50/50<br>Solution as listed<br>on the label. | The devices are<br>disposable devices<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand to prevent<br>contamination<br>between patient<br>and examiner.<br>These gloves were<br>tested for use<br>with fentanyl<br>citrate as listed on<br>the label. | Similar | | Technological<br>Characteristics | Colored, 9.5 inch,<br>chlorinated, nitrile,<br>powder-free,<br>textured,<br>ambidextrous, non-<br>sterile patient<br>examination glove | Colored, 9.5 inch,<br>chlorinated, nitrile,<br>powder-free,<br>textured,<br>ambidextrous,<br>non-sterile patient<br>examination glove | Colored, 9.5 inch,<br>chlorinated,<br>nitrile, powder-<br>free, textured<br>fingertip,<br>ambidextrous,<br>non-sterile patient<br>examination glove | Colored, 9.5 inch,<br>chlorinated,<br>nitrile, powder-<br>free, textured<br>fingertip,<br>ambidextrous,<br>non-sterile patient<br>examination glove | Similar | | Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL | Similar | | Glove Length | 9.5 inch | 9.5 inch | 12 inch | 9.5 inch | Similar | | Texture | Textured on dorsal<br>and palmar sides<br>through the<br>fingertips | Textured on dorsal<br>and palmar sides<br>through the<br>fingertips | Textured<br>fingertips | Textured<br>fingertips | Similar | | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized, maroon-colored font, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a gray, sans-serif font. The logo is clean and professional, and the colors are muted and sophisticated. | 14. Standard | Subject Device<br>Halyard Black<br>Nitrile Powder-<br>Free Exam Gloves<br>with Textured Grip | Predicate Device K220373 | Reference Device<br>K213929 | Reference<br>Device<br>K200633 | Comparison | | | | | | | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------|------------|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------| | ASTM D6978-05<br>Standard<br>Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves<br>to Permeation<br>by<br>Chemotherapy<br>Drugs | The following<br>chemotherapy<br>drugs and<br>concentration had<br>NO breakthrough<br>detected up to 240<br>minutes:<br>Cisplatin, 1 mg/ml<br>Cyclophosphamide,<br>20 mg/ml<br>Dacarbazine, 10<br>mg/ml<br>Doxorubicin HCl, 2<br>mg/ml<br>Etoposide, 20<br>mg/ml<br>Fluorouracil, 50<br>mg/ml<br>Ifosfamide, 50<br>mg/ml<br>Mitoxantrone HCl,<br>2 mg/ml<br>Paclitaxel, 6 mg/ml<br>Vincristine Sulfate,<br>1 mg/ml<br>CAUTION: The | This specialty glove has also<br>been tested for use with the<br>Opioid drugs Fentanyl citrate,<br>Heroin, and both Opioids in<br>simulated Gastric Acid.<br>Test Opioid Drug Concentration Minimum<br>Breakthrough Time Fentanyl citrate (injectable) (100mcg/2ml) >240 minutes Fentanyl citrate (injectable)<br>+ Heroin (100mcg/2ml)<br>+(saturated solution) >240 minutes Fentanyl citrate (injectable)<br>+ Heroin in Simulated Gastric<br>Acid Mix 100mcg/2ml<br>Saturated Solution into<br>simulated Gastric Acid >240 minutes | | | | | | | | | | | | | The following<br>chemotherapy<br>drugs and<br>concentration had<br>NO breakthrough<br>detected up to<br>240 minutes:<br>Azacitidine (25<br>mg/ml)<br>Bendamustine HCl<br>(5 mg/ml)<br>Bleomycin Sulfate<br>(15 mg/ml)<br>Bortezomib (1<br>mg/ml)<br>Busulfan (6<br>mg/ml)<br>Capecitabine (26<br>mg/ml)<br>Carboplatin (10<br>mg/ml) Carfilzomib<br>(2 mg/ml)<br>Cetuximab (2<br>mg/ml)<br>Chloroquine (50<br>mg/ml)<br>Cisplatin (1 | The following<br>drugs<br>showed not<br>breakthrough<br>at 240<br>minutes:<br>Fentanyl<br>Citrate, 100<br>mcg/2ml | Similar | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon font on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a gray, serif font. | following<br>chemotherapy<br>drug and<br>concentration<br>showed<br>breakthrough<br>detected in less<br>than 60 minutes:<br>Carmustine, 3.3<br>mg/ml: Do not use | mg/ml) Cladribine<br>(1 mg/ml)<br>Cyclophosphamide<br>(20 mg/ml)<br>Cyclosporin A (100<br>mg/ml)<br>Cytarabine<br>(Cytosine) (100<br>mg/ml) Cytovene<br>(Ganciclovir) (10<br>mg/ml)<br>Dacarbazine<br>(DTIC) (10 mg/ml)<br>Dactinomycin (0.5<br>mg/ml)<br>Daunorubicin HCl<br>(5 mg/ml)<br>Decitabine (5<br>mg/ml)<br>Docetaxel (10<br>mg/ml)<br>Doxorubicin HCl (2<br>mg/ml)<br>Epirubicin HCl<br>(Ellence) (2<br>mg/ml) Etoposide<br>(Toposar) (20<br>mg/ml)<br>Fludarabine (25<br>mg/ml) 5-<br>Fluorouracil (50<br>mg/ml)<br>Fulvestrant (50<br>mg/ml)<br>Gemcitabine (38<br>mg/ml)<br>Idarubicin (1<br>mg/ml) Ifosfamide<br>(50 mg/ml)<br>Irinotecan HCl (20<br>mg/ml) Leuprolide<br>Acetate Salt (5<br>mg/ml)<br>Mechlorethamine<br>HCl (1 mg/ml)<br>Melphalan (5<br>mg/ml)<br>Methotrexate (25<br>mg/ml) Mitomycin<br>C (0.5 mg/ml)<br>Mitoxantrone (2<br>mg/ml) Oxaliplatin<br>(5 mg/ml)<br>Paclitaxel (6<br>mg/ml)<br>Pemetrexed (25<br>mg/ml) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CAUTION: The<br>following<br>chemotherapy<br>drug and<br>concentration<br>showed<br>breakthrough<br>detected in less<br>than 120 minutes:<br>Thiotepa, 10<br>mg/ml: Do not use | | | Warning: Not for<br>use with<br>Carmustine,<br>Thiotepa | | | The following<br>hazardous drugs<br>(opioids) and<br>concentration had<br>NO breakthrough<br>detected up to 240<br>minutes:<br>Fentanyl Citrate<br>Injection (50 mcg/5<br>ml) Simulated<br>Gastric Acid<br>Fluid/Fentanyl<br>Citrate Injection<br>Mix 50/50 Solution | | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the "O". To the right of the letters is the company name "Owens & Minor" in a gray color. The font is sans-serif and the overall design is clean and professional. | Biocompatibility<br>Sensitization<br>ISO 10993-10 | | | | | | | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------| | | Under the<br>conditions of the<br>study, not a<br>sensitizer. | Under the conditions of the<br>study, not a sensitizer. Under<br>the conditions of the study,<br>not an irritant. | Raltitrexed (0.5 mg/ml) Retrovir<br>(10 mg/ml)<br>Rituximab (10 mg/ml)<br>Temsirolimus (25 mg/ml)<br>Topotecan HCl (1 mg/ml) Triclosan<br>(2 mg/ml)<br>Trisenox (1 mg/ml)<br>Vinblastine Sulfate<br>(1 mg/ml)<br>Vincristine (1 mg/ml)<br>Vinorelbine (10 mg/ml)<br>Zoledronic Acid<br>(0.8 mg/ml)<br>The following<br>chemotherapy<br>drugs and<br>concentration<br>showed<br>breakthrough<br>detected in less<br>than 90 minutes:<br>Carmustine (3.3<br>mg/ml) No<br>breakthrough up<br>to 55.3 minutes.<br>Thiotepa (10<br>mg/ml) No<br>breakthrough up<br>to 78.8 minutes.<br>Warning- Not for<br>use with<br>Carmustine and<br>ThioTEPA<br>No breakthrough<br>was detected up<br>to 240 minutes for<br>Fentanyl Citrate<br>Injection (100<br>mcg/2 ml) and<br>Simulated Gastric<br>Acid<br>Fluid/Fentanyl<br>Citrate Injection<br>Mix 50/50<br>Solution | Under the<br>conditions of the<br>study, not a<br>sensitizer. Under<br>the conditions of<br>the study | Under the<br>conditions of<br>the study,<br>not a<br>sensitizer.<br>Under the | Same | | | | | irritant. | conditions of<br>the study,<br>not an<br>irritant. | | | | Biocompatibility<br>Cytotoxicity<br>ISO 10993-5 | Not Performed | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity to<br>L929 cells. Cytotoxicity<br>concern was addressed by<br>acute systematic toxicity<br>testing. | Not Performed | Not<br>Performed | Different<br>from<br>K220373<br>Same as<br>K200633<br>and<br>K213929 | | | Biocompatibility<br>Acute Systemic<br>Toxicity<br>ISO 10993-11 | Under the<br>conditions of the<br>study, the device<br>extract does not<br>induce acute<br>systemic toxicity<br>response. | Under the conditions of this<br>study, there was no evidence<br>of acute systemic toxicity. | Under the<br>conditions of this<br>study, there was<br>no evidence of<br>acute systemic<br>toxicity. | Under the<br>conditions of<br>this study,<br>there was no<br>evidence of<br>acute<br>systemic<br>toxicity. | Same | | | Biocompatibility<br>Irritation<br>ISO 10993-23 | Under the<br>conditions of the<br>study, not an<br>irritant. | Not Performed | Not Performed | Not<br>Performed | Different | | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a gray color. #### 15. SUMMARY OF NON-CLINICAL TESTING #### Biocompatibility Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface Device and duration of contact is A-Limited (≤24h). The following tests for the proposed device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff-Medical Guidance Manual issued on January 22, 2008. - ISO 10993-23: Primary Skin Irritation - ISO 10993-10: Dermal Sensitization - · ISO 10993-11: Systemic Toxicity ## Performance Testing Physical Performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application 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 (2023) Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs and fentanyl citrate. To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance to the relevant test methods cited below: - ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves - • ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves - ASTM D6978-05 Standard Practice for Assessment of resistance of Medical Gloves to Permeation by . Chemotherapy Drugs {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray. For the test result, we can find the product can meet the requirements as its intended use indicated. | Test Method | Standard | Acceptance Criteria | Results | |-----------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Dimensions<br>(Length) (Width)<br>(Thickness) | ASTM D6319 | | PASS | | | Length | ≥230 mm | | | | Palm Width Size | X-Small: 60 – 80 mm<br>Small: 70 - 90 mm<br>Med: 85–105 mm<br>Large: 100 - 120 mm<br>X-Large: 110-130 mm<br>XX-Large: 120-140 mm | | | | Finger thickness | ≥0.05 mm | | | | Palm thickness | ≥0.05 mm | | | | Cuff thickness | ≥0.05 mm | | | Physical Properties | ASTM D 6319 | AQL 4.0<br>Before Aging<br>Tensile Strength: ≥14 MPa<br>Ultimate elongation: ≥500%<br>After Aging<br>Tensile Strength: ≥14 MPa<br>Ultimate elongation: ≥400% | PASS | | Freedom from<br>Pinholes | ASTM D 6319<br>ASTM D 5151 | AQL 2.5%<br>No leakage | PASS | | Residual Powder | ASTM D 6124<br>ASTM D 6319 | ≤ 2 mg / glove | PASS | | Permeation by<br>Chemotherapy Drugs | ASTM D6978 | Refer to the above<br>table | PASS | | Test for irritation | ISO 10993, Part 23 | No dermal<br>irritation<br>reactions | PASS | | Test for acute<br>systemic toxicity | ISO 10993, Part 11 | Under the conditions<br>of the study, the<br>device extract does<br>not induce acute<br>systemic toxicity<br>response. | PASS | | Test for skin<br>sensitization | ISO 10993, Part 10 | No dermal reactions<br>indicative of delayed<br>contact<br>hypersensitivity. | PASS | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a light gray color. The letters "OM" have horizontal lines going through them. 16. CLINICAL TEST CONCLUSION No clinical study is included in this submission. ## 17. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the subject device in K242558, Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220373.