GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION June 3, 2025 Glove One, LLC % Terrie Heidemann Consultant Terrie M Heidemann 3085 N Broadway Escondido, California 92026 Re: K243796 Trade/Device Name: GLOVEONE™ Powder-Free Nitrile Examination Gloves - Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] 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: April 28, 2025 Received: May 1, 2025 Dear Terrie Heidemann: 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243796 - Terrie Heidemann Page 2 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K243796 - Terrie Heidemann Page 3 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K243796 Device Name GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] 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 and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug Tested | Breakthrough Time (minutes) | | --- | --- | | Cisplatin 1 mg/ml (1,000 ppm) | >240 min | | Cyclophosphamide 20 mg/ml (20,000 ppm) | >240 min | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 min | | Doxorubicin HCL 2 mg/ml (2,000 ppm) | >240 min | | Etoposide 20 mg/ml (20,000 ppm) | >240 min | | Fluorouracil 50 mg/ml (50,000 ppm) | >240 min | | Ifosamide 50 mg/ml (50,000 ppm) | >240 min | | Mitroxantrone HCL 2 mg/ml (2,000 ppm) | >240 min | | Paclitaxel 6 mg/ml (16,000 ppm) | >240 min | | Vincristine Sulfate 1 mg/ml (1,000 ppm) | >240 min | | Carmustine 3.3 mg/ml (3,000 ppm) | 12.3 minutes | | Thiotepa 10 mg/ml (10,000 ppm) > 240 min | 13.4 minutes | Fentanyl Tested Fentanyl Citrate Injection, 100 mcg/2 mL Breakthrough Time (minutes) &gt;240 min WARNING: The following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes Thiotepa (THT) (10.0 mg/ml) 13.4 minutes Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 {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." FORM FDA 3881 (8/23) Page 2 of 2 {5} K243796 # 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)] ## Submitter / 510(k) Sponsor GLOVEONE, LLC 205 Raceway Drive Suite 3 Mooresville, NC 28117 Applicant Contact: Terrie Heidemann, Regulatory Affairs 3085 N Broadway Escondido, CA 92026 USA +1.760.855.0613 terriemheidemann@gmail.com Summary Preparation Date:29May2025 ## Type of 510(k) Submission Traditional Device Classification: Class I ## 510(k) Number: K243796 ## Device Name/Classification Name of Device: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] Common Name: Patient Examination Glove, Specialty Classification Name: Polymer Patient Exam Glove, Medical Gloves with Chemotherapy/Fentanyl Labeling Claims Product Code: LZA, LZC, OPJ, QDO Classification Panel: General Hospital Regulation #: 21 CFR 880.6250 ## Predicate Device Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)- Regular Cuff – K193666 Product Code: LZA, OPJ, QDO ## Applicant Name: Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 Page 1 of 13 {6} K243796 # Device Description GLOVEONE™, Powder-Free Nitrile Examination Gloves - Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex. GLOVEONE™, Powder-Free Nitrile Examination Gloves - Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large. Table 1: GLOVEONE™ Powder-Free Nitrile Examination Gloves | Glove Type | Model Number | Size | Glove Count | | --- | --- | --- | --- | | GLOVEONE™ | GO1111-100 | Extra-Small | 100 | | Powder Free, Nitrile | GO1111-200 | | 200 | | Exam Glove–Non-sterile | GO1112-100 | Small | 100 | | | GO1112-200 | | 200 | | | GO1113-100 | Medium | 100 | | | GO1113-200 | | 200 | | | GO1114-100 | Large | 100 | | | GO1114-200 | | 200 | | | GO1115-100 | Extra-Large | 100 | | | GO1115-200 | | 200 | The gloves are designed and manufactured in accordance with the ASTM D6319-19 (2023) Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs as well as for use with Fentanyl per ASTM D6978-05 (Reapproved 2019). # Physical Description GLOVEONE™ (Green Colored), Nitrile, powder free, non-sterile, textured fingertips, ambidextrous, beaded cuff, examination gloves with online chlorination on the grip side. # 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 and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. {7} K243796 | Chemotherapy Drug Tested | Breakthrough Time (minutes) | | --- | --- | | Cisplatin 1 mg/ml (1,000 ppm) | >240 min | | Cyclophosphamide 20 mg/ml (20,000 ppm) | >240 min | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 min | | Doxorubicin HCL 2 mg/ml (2,000 ppm) | >240 min | | Etoposide 20 mg/ml (20,000 ppm) | >240 min | | Fluorouracil 50 mg/ml (50,000 ppm) | >240 min | | Ifosamide 50 mg/ml (50,000 ppm) | >240 min | | Mitroxantrone HCL 2 mg/ml (2,000 ppm) | >240 min | | Paclitaxel 6 mg/ml (16,000 ppm) | >240 min | | Vincristine Sulfate 1 mg/ml (1,000 ppm) | >240 min | | Carmustine 3.3 mg/ml (3,000 ppm) | 12.3 minutes (21.2, 12.8, 12.6) | | Thiotepa 10 mg/ml (10,000 ppm) | 13.4 minutes (17.1, 15.4, 13.4) | | Fentanyl Tested | Breakthrough Time (minutes) | | --- | --- | | Fentanyl Citrate Injection, 100 mcg/2 mL | >240 min | **WARNING: Not for use with Carmustine or Thiotepa The following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes Thiotepa (THT) (10.0 mg/ml) 13.4 minutes Page 3 of 13 {8} K243796 Comparison of Technological Characteristics | Device Characteristics | Proposed Device | Medline Predicate Device | Comparison Analysis | | --- | --- | --- | --- | | Product Name | GLOVEONETM, Powder Free, Nitrile Examination Glove – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff | N/A | | 510(k) | K243796 | K193666 | N/A | | Product Owner | GLOVEONETM | Medline Industries, Inc. | N/A | | Product Code | LZA, LZC, OPJ, QDO | LZA, OPJ, QDO | Similar | | Intended 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 and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | 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 and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Materials | Powder-Free Nitrile | Powder-Free Nitrile | Same | | Color | Green | Blue | Similar | | Sizes | xs-small, small, medium, large, x-large | xs-small, small, medium, large, x-large | Same | | Dimensions – Length | Complies with: ASTM D6319-19 (2023) 220mm min | Complies with: ASTM D6319-10 220mm min | Same | | Dimensions – Width | Complies with: ASTM D6319-19 (2023) 70mm min | Complies with: ASTM D6319-10 70mm min | Same | | Dimensions – Thickness | Complies with: ASTM D6319-19 (2023) Palm – 0.05 mm min Finger – 0.05mm min | Complies with: ASTM D6319-10 Palm – 0.05 mm min Finger – 0.05mm min | Same | | Physical Properties | Complies with: ASTM D6319-19 (2023) minimum Tensile Strength: Before Aging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation: | Complies with: ASTM D6319-10 minimum Tensile Strength: Before Aging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation: | Same | Page 4 of 13 {9} K243796 | Device Characteristics | Proposed Device | Medline Predicate Device | Comparison Analysis | | --- | --- | --- | --- | | | Before Aging 500% min. After Aging 400%, min. | Before Aging 500% min. After Aging 400%, min. | | | Freedom from Holes | Complies with: ASTM D6319-19 (2023) and ASTM D5151-19 G-1, AQL 1.5 | Complies with: ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 | Same | | Powder or Powder-Free | Powder-Free | Powder-Free | Same | | Residual Powder | Complies with: ASTM D6319-19 (2023) ≤ 2 mg per glove | Complies with: ASTM D6319-10 ≤ 2 mg per glove | Same | | Contact Durations | Limited ≤ 24 hours | Limited ≤ 24 hours | Same | | Biocompatibility | AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic. | AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic. | Same | | | AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer. | AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer. | | | | AAMI/ANSI/ISO 10993-23: Under the conditions of the study, the subject device is not a primary skin irritant. | AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin irritant. | | | | AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic. | AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic. | | | Sterility | Non-sterile | Non-sterile | Same | | Rx Only or OTC | Over the Counter | Over the Counter | Same | Page 5 of 13 {10} K243796 | Tested Chemotherapy Drugs and Fentanyl Citrate | • Cisplatin 1 mg/ml (1,000 ppm) • Cyclophosphamide 20 mg/ml (20,000 ppm) • Dacarbazine 10 mg/ml (10,000 ppm) • Doxorubicin HCL 2 mg/ml (2,000 ppm) • Etoposide 20 mg/ml (20,000 ppm) • Fluorouracil 50 mg/ml (50,000 ppm) • Ifosamide 50 mg/ml (50,000 ppm) • Mitroxantrone HCL 2 | • Cisplatin 1 mg/ml (1,000 ppm) • Cyclophosphamide 20 mg/ml (20,000 ppm) • Dacarbazine 10 mg/ml (10,000 ppm) • Doxorubicin HCL 2 mg/ml (2,000 ppm) • Etoposide 20 mg/ml (20,000 ppm) • Fluorouracil 50 mg/ml (50,000 ppm) • Ifosamide 50 mg/ml (50,000 ppm) • Mitroxantrone HCL 2 | Similar | | --- | --- | --- | --- | Page 6 of 13 {11} K243796 | Device Characteristics | Proposed Device | Medline Predicate Device | Comparison Analysis | | --- | --- | --- | --- | | | mg/ml (2,000 ppm) • Paclitaxel 6 mg/ml (16,000 ppm) • Vincristine Sulfate 1 mg/ml (1,000 ppm) • Carmustine 3.3 mg/ml (3,000 ppm) • Thiotepa 10 mg/ml (10,000 ppm) • Fentanyl Citrate Injection 100 mcg/2 ml | mg/ml (2,000 ppm) • Paclitaxel 6 mg/ml (16,000 ppm) • Vincristine Sulfate 1 mg/ml (1,000 ppm) • Carmustine 3.3 mg/ml (3,000 ppm) • Thiotepa 10 mg/ml (10,000 ppm) • Fentanyl Citrate Injection 100 mcg/2 ml **Medline evaluated 38 additional drugs which are not being claimed as part of the GLOVEON™ submission** • Arsenic Trioxide 1.0 mg/ml (1,000 ppm) • Azacitidine (Vidaza) 25.0 mg/ml (25,000 ppm) • Bendamustine 5.0 mg/ml (5,000 ppm) • Bleomycin 15.0 mg/ml (15,000 ppm) • Bortezomib 1.0 mg/ml (1,000 ppm) • Busulfan 6.0 mg/ml (6,000 ppm) • Carboplatin 10 mg/ml (10,000 ppm) • Carfilzomib 2.0 mg/ml (2,000 ppm) • Cetuximab 2.0 mg/ml (2,000 ppm) • Cytarabine 100.0 mg/ml (100,000 ppm) • Cytovene 10.0 mg/ml (10,000 ppm) • Daunorubicin 5.0 mg/ml (5,000 ppm) • Decitabine 5.0 mg/ml (5,000 ppm) | | Page 7 of 13 {12} K243796 | Device Characteristics | Proposed Device | Medline Predicate Device | Comparison Analysis | | --- | --- | --- | --- | | | | • Docetaxel 10.0 mg/ml (10,000 ppm) • Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) • Fludarabine 25.0 mg/ml (25,000 ppm) • Fulvestrant 50.0 mg/ml (50,000 ppm) • Gemcitabine (Gemzar) 38.0 mg/ml (38,000 ppm) • Idarubicin 1.0 mg/ml (1,000 ppm) • Irinotecan 20.0 mg/ml (20,000 ppm) • Mechlorethamine HCL 1.0 mg/ml (1,000 ppm) • Melphalan 5.0 mg/ml (5,000 ppm) • Methotrexate 25.0 mg/ml (25,000 ppm) • Mitomycin C 0.5 mg/ml (50 ppm) • Oxaliplatin 2.0 mg/ml (2,000 ppm) • Paraplatin 10.0 mg/ml (10,000 ppm) • Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) • Pertuzumab 30.0 mg/ml (30,000 ppm) • Raltitrexed 0.5 mg/ml (500 ppm) • Retrovir 10 mg/ml (10,000 ppm) • Rituximab 10 mg/ml (10,000 ppm) • Temsirolimus 25.0 mg/ml (25,000 ppm) • Topotecan HCl 1.0 mg/ml (1,000 ppm) • Trastuzumab 21.0 mg/ml (21,000 ppm) • Trisonex 1.0 mg/ml (1,000 ppm) • Vinblastine 1 mg/ml | | Page 8 of 13 {13} K243796 | Device Characteristics | Proposed Device | Medline Predicate Device | Comparison Analysis | | --- | --- | --- | --- | | | | (1,000 ppm) • Vinorelbine 10 mg/ml (10,000 ppm) • Zoledronic Acid 0.8 mg/ml (800 ppm) | | Page 9 of 13 {14} K243796 # Summary of non-clinical testing Biocompatibility Testing | Name of Test/Citation | Purpose | Acceptance Criteria | Results | | --- | --- | --- | --- | | ISO 10993-23: 2021 Biological Evaluation of Medical Devices, Part 23 – Tests for Irritation | Irritation Testing | Pass/Fail | Pass Under the conditions of the study, the subject device is not a primary skin irritant | | ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Test for Skin Sensitization | Sensitization Testing | Pass/Fail | Pass Under the conditions of the study, the subject device is not a primary skin sensitizer | | ISO 10993-5: 2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | Cytotoxicity Testing | Pass/Fail | Failed Under the conditions of the study, the subject device is cytotoxic | | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Test for Systemic Toxicity | Acute Systemic Toxicity Testing | Pass/Fail | Pass Under the conditions of the study, the subject device does not exhibit acute systemic toxicity | Specification Performance Testing | Characteristics | Reference Test Method & Sampling | Inspection Level | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Dimension (length, width, thickness) | ASTM D6319-19 (2023) | S-2 | AQL 4.0 | Pass | | Tensile strength and Ultimate Elongation | ASTM D6319-19 (2023) | S-2 | AQL 4.0 | Pass | | Water Leak | ASTM D5151-19 (2023) and ASTM D6319-19 (2023) | G-1 | AQL 2.5 | Pass | | Powder Residue | ASTM D6124-06 (2022) | N/A | < 2 mg/glove | Pass | Page 10 of 13 {15} K243796 # Physical Dimensions The table below summarizes the physical dimension results for the GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] ASTM D6319-19 (2023) Test Results | Characteristics | Device Specification | Complies with Standard (Y/N) | | --- | --- | --- | | Glove Length | x-small – ≥ 220 mm small – ≥ 220 mm medium – ≥ 230 mm large – ≥ 230 mm x-large – ≥ 230 mm | Yes | | Palm Width | x-small – 70 mm small – 80 mm medium – 95 mm large – 110 mm x-large – 120 mm Tolerance (± 10 mm) | Yes | | Thickness Finger | 0.05 mm min. | Yes | | Thickness Palm | 0.05 mm min | Yes | Page 11 of 13 {16} K243796 # Freedom from Holes Glove samples of each size (extra-small, small, medium, large, and extra-large) were tested for freedom from holes as per ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves and the FDA 1000ml Water Leak. Test per 21 CFR 800.20. The results for all sizes (XS/S/M/L/XL) are summarized in Tables below. | Characteristics | Specification | Device Performance | Complies with Standard (Y/N) | | --- | --- | --- | --- | | Freedom from Holes | ASTM D5151-19 and ASTM D 6319-19 (2023), G-1 AQL 2.5 | 0 failures observed | Yes | # Powder Content Glove samples of the medium size were tested for powder content as per ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. The average results are summarized below: | Characteristics | Specification | Device Performance | Complies with Standard (Y/N) | | --- | --- | --- | --- | | Powder Content per Glove | Less than 2 mg/glove | Less than 2 mg/glove | Yes | # Permeation Testing Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The gloves were tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs and for permeation of Fentanyl Citrate Injection. A summary of the minimum breakthrough times is provided in Tables below. # Chemotherapy Drugs Tested Summarized in Table below are the drugs the proposed devices have been tested for use with per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Page 12 of 13 {17} K243796 | Chemotherapy Drug Tested | Breakthrough Time (minutes) | | --- | --- | | Cisplatin 1 mg/ml (1,000 ppm) | >240 min | | Cyclophosphamide 20 mg/ml (20,000 ppm) | >240 min | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 min | | Doxorubicin HCL 2 mg/ml (2,000 ppm) | >240 min | | Etoposide 20 mg/ml (20,000 ppm) | >240 min | | Fluorouracil 50 mg/ml (50,000 ppm) | >240 min | | Ifosamide 50 mg/ml (50,000 ppm) | >240 min | | Mitroxantrone HCL 2 mg/ml (2,000 ppm) | >240 min | | Paclitaxel 6 mg/ml (16,000 ppm) | >240 min | | Vincristine Sulfate 1 mg/ml (1,000 ppm) | >240 min | | Carmustine 3.3 mg/ml (3,000 ppm) | 12.3 minutes (21.2, 12.8, 12.6) | | Thiotepa 10 mg/ml (10,000 ppm) | 13.4 minutes (17.1, 15.4, 13.4) | | Fentanyl Tested | Breakthrough Time (minutes) | | --- | --- | | Fentanyl Citrate Injection, 100 mcg/2 mL | >240 min | ## Summary of Clinical Testing Clinical testing is not required for this device. ## Conclusion The conclusions drawn from the nonclinical tests demonstrate that the GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] are as safe, as effective and performs as well as or better than the legally marketed predicate device. 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