Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

{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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 17, 2023 Hartalega NGC SDN. BHD. Nurul Aisyah Kong General Manager-Ouality Assurance No. 1. Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang. Selangor Darul Ehsan 43900 Malaysia Re: K223437 Trade/Device Name: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: March 15, 2023 Received: March 20, 2023 Dear Nurul Aisyah Kong: 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. 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 located 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}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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-regulatoryassistance/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. # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223437 #### Device Name Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) #### Indications for Use (Describe) Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |-----------------------------------------|------------------------------------------------| | 5-Azacytidine (25.0 mg/ml) | > 240 | | Carboplatin (10.0 mg/ml) | > 240 | | Carmustine (3.3 mg/ml) | 12.1 | | Cisplatin (1.0 mg/ml) | > 240 | | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | | Dacarbazine (10.0 mg/ml) | > 240 | | Doxetacel (10.0 mg/ml) | > 240 | | Doxorubicin HCI (2.0 mg/ml) | > 240 | | Epirubicin (2.0 mg/ml) | > 240 | | Etoposide (20.0 mg/ml) | > 240 | | Fluorouracil (50.0 mg/ml) | > 240 | | Gemcitabine (38.0 mg/ml) | > 240 | | Ifosfamide (50.0 mg/ml) | > 240 | | Irinotecan (20.0 mg/ml) | > 240 | | Methotrexate (25.0 mg/ml) | > 240 | | Mitomycin C (0.5 mg/ml) | > 240 | | Mitoxantrone (2.0 mg/ml) | > 240 | | Oxalipatin (5.0 mg/ml) | > 240 | | Paclitaxel (6.0 mg/ml) | > 240 | | Thiotepa (10.0 mg/ml) | 37.8 | | Vincristine Sulfate (1.0 mg/ml) | > 240 | | Oncovin (1.0 mg/ml) | > 240 | | Vinorelbine (10.0mg/ml) | > 240 | | Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | |-----------------------------------------|------------------------------------------------| | Fentanyl Citrate Injection (100mcg/2ml) | >240 | Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes and 37.8 minutes. Warning: Do not use with Carmustine. 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) {3}------------------------------------------------ #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ ### 510(k) SUMMARY # K223437 # BIODEGRADABLE NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE (FUSION COLOUR) (The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92) # SUBMISSION APPLICANT | Date Prepared | : | May 15, 2023 | |-----------------------------------|---|----------------------------------------------------------------------------------------------------------------| | Name | : | Hartalega NGC Sdn. Bhd. | | Address | : | No. 1, Persiaran Tanjung,<br>Kawasan Perindustrian Tanjung,<br>Sepang, Selangor Darul Ehsan, 43900<br>Malaysia | | Establishment Registration Number | : | 3011200663 | # SUBMISSION CORRESPONDENT AND/OR PREPARER | Contact Name | : | Nurul Aisyah Kong | |---------------|---|-------------------------------------| | Contact Title | : | General Manager - Quality Assurance | | Phone Number | : | (603) 3280 3888 | | Fax Number | : | (603) 3271 0135 | | Contact Email | : | wkkong@hartalega.com.my | #### DEVICE IDENTIFICATION | Common Name of the Device | : | Non-Powdered Patient Examination Glove | |-------------------------------|---|---------------------------------------------------------------------------------------------------------------------------------------| | Trade Name (Proprietary Name) | : | Biodegradable Nitrile Powder Free Examination Glove Tested for<br>Use with Chemotherapy Drugs and Fentanyl Citrate<br>(Fusion Colour) | | Device Class | : | 1 | | Product Code | : | LZA, LZC, QDO, OPJ | | Regulation Number | : | 21 CFR 880.6250 | | Reason for 510(k) Submission | : | New device | {5}------------------------------------------------ # PREDICATE DEVICE INFORMATION | 510(k) Number | Tradename | | Product Code | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---|--------------------------------------------------------------|--| | K200581 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use<br>with Chemotherapy Drugs and Fentanyl Citrate (Blue) | | LZA. LZC, QDO | | | | | | | | | Regulation Name | | : | Non-Powdered Patient Examination Glove | | | Trade Name (Proprietary Name)<br>Biodegradable Nitrile Powder Free Examination Glove Tested for Use<br>: | | | | | | | | | with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | | | Device Class | | | | | | Product Code | | : | LZA, LZC, QDO, OPJ | | | Regulation Number | | : | 21 CFR 880.6250 | | ## DESCRIPTION OF THE DEVICE: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex. #### INDICATIONS FOR USE: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentary1 Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. {6}------------------------------------------------ | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |-------------------------------------|------------------------------------------------| | 5- Azacytidine, 25.0 mg/ml | > 240 | | Carboplatin, 10.0 mg/ml | > 240 | | Carmustine (3.3 mg/ml) | 12.1 | | Cisplatin (1.0 mg/ml) | > 240 | | Cyclophosphamide (20.0 mg/ml) | > 240 | | Dacarbazine (10.0 mg/ml) | > 240 | | Docetaxel, 10.0 mg/ml | > 240 | | Doxorubicin HCL (2.0 mg/ml) | > 240 | | Epirubicin, 2.0 mg/ml | > 240 | | Etoposide (20.0 mg/ml) | > 240 | | Fluorouracil (50.0 mg/ml) | > 240 | | Gemcitabine, 38.0 mg/ml | > 240 | | Ifosfamide, 50.0 mg/ml | > 240 | | Irinotecan, 20.0 mg/ml | > 240 | | Methotrexate (25.0 mg/ml) | > 240 | | Mitomycin C (0.5 mg/ml) | > 240 | | Mitoxantrone, 2.0 mg/ml | > 240 | | Oxaliplatin, 2.0 mg/ml | > 240 | | Paclitaxel (6.0 mg/ml) | > 240 | | Thiotepa (10.0 mg/ml) | 37.8 | | Vincristine Sulfate (1.0 mg/ml) | > 240 | | Oncovin (1.0 mg/ml) | > 240 | | Vinorelbine, 10.0 mg/ml | > 240 | | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes. Warning: Do not use with Carmustine. {7}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE: | Characteristics<br>and Parameters | Subject Device | Predicate Device<br>(K200581) | Discussion | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Trade Name | Biodegradable Nitrile Powder Free<br>Examination Glove Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate<br>(Fusion Colour) | Biodegradable Nitrile Powder Free<br>Examination Glove Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate<br>(Blue) | - | | Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same | | Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Similar | | Classification | 1 | 1 | Same | | Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Regulation<br>Name | Non-Powdered Patient Examination Glove | Non-Powdered Patient Examination Glove | Same | | Indications for<br>Use | A non-sterile disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand to prevent contamination<br>between patient and examiner. It is also tested<br>to be used against Chemotherapy Drugs and<br>Fentanyl Citrate.<br>The gloves were tested for use with<br>chemotherapy drugs as per ASTM D6978-05<br>(Reapproved 2019) Standard Practice for<br>Assessment of Resistance of Medical Gloves<br>to Permeation by Chemotherapy Drugs. | A non-sterile disposable device intended for<br>medical purpose that is worn on the examiner's<br>hand to prevent contamination between patient<br>and examiner. It is also tested to be used against<br>Chemotherapy Drugs and Fentanyl Citrate.<br>The gloves were tested for<br>use with<br>chemotherapy drugs as per ASTM D6978-05<br>(Reapproved 2013) Standard Practice for<br>Assessment of Resistance of Medical Gloves to<br>Permeation by Chemotherapy Drugs. | Similar | {8}------------------------------------------------ | Characteristics<br>and Parameters | Subject Device | | Predicate Device<br>(K200581) | | Discussion | |-----------------------------------|----------------------------------------|---------------------------------------------------------|------------------------------------|---------------------------------------------------------|------------| | | Chemotherapy Drug and<br>Concentration | Minimum<br>Breakthrough<br>Detection Time<br>in Minutes | Chemotherapy Drug<br>Concentration | Minimum<br>Breakthrough<br>Detection Time<br>in Minutes | | | Test<br>Chemotherapy<br>Drugs | 5-Azacytidine, 25.0mg/ml | > 240 | 5-Azacytidine, 25.0mg/ml | > 240 | Similar | | | Carboplatin, 10.0 mg/ml | > 240 | Carboplatin, 10.0 mg/ml | > 240 | | | | Carmustine (3.3 mg/ml) | 12.1 | Carmustine (3.3 mg/ml) | 21.4 | | | | Cisplatin (1.0 mg/ml) | > 240 | Cisplatin (1.0 mg/ml) | > 240 | | | | Cyclophosphamide (20.0 mg/ml) | > 240 | Cyclophosphamide (20.0 mg/ml) | > 240 | | | | Dacarbazine (10.0 mg/ml) | > 240 | Dacarbazine (10.0 mg/ml) | > 240 | | | | Docetaxel, 10.0 mg/ml | > 240 | Docetaxel, 10.0 mg/ml | > 240 | | | | Doxorubicin HCL (2.0 mg/ml) | > 240 | Doxorubicin HCL (2.0 mg/ml) | > 240 | | | | Epirubicin HCL, 2.0 mg/ml | > 240 | Epirubicin HCL, 2.0 mg/ml | > 240 | | | | Etoposide (20.0 mg/ml) | > 240 | Etoposide (20.0 mg/ml) | > 240 | | | | Fluorouracil (50.0 mg/ml) | > 240 | Fluorouracil (50.0 mg/ml) | > 240 | | | | Gemcitabine, 38.0 mg/ml | > 240 | Gemcitabine, 38.0 mg/ml | > 240 | | | | Ifosfamide, 50.0 mg/ml | > 240 | Ifosfamide, 50.0 mg/ml | > 240 | | | | Irinotecan, 20.0 mg/ml | > 240 | Irinotecan, 20.0 mg/ml | > 240 | | | | Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240 | | | | Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240 | | | | Mitomycin C (0.5 mg/ml) | > 240 | Mitomycin C (0.5 mg/ml) | > 240 | | | | Mitoxantrone, 2.0 mg/ml | > 240 | Mitoxantrone, 2.0 mg/ml | > 240 | | | | Oxaliplatin, 5.0 mg/ml | > 240 | Oxaliplatin, 5.0 mg/ml | > 240 | | | | Paclitaxel (6.0 mg/ml) | > 240 | Paclitaxel (6.0 mg/ml) | > 240 | | | | Thiotepa (10.0 mg/ml) | 37.8 | Thiotepa (10.0 mg/ml) | 67.2 | | | | Vincristine Sulfate (1.0 mg/ml) | > 240 | Vincristine Sulfate (1.0 mg/ml) | > 240 | | | | Oncovin (1.0 mg/ml) | > 240 | Oncovin (1.0 mg/ml) | > 240 | | | | Vinorelbine, 10.0 mg/ml | > 240 | Vinorelbine, 10.0 mg/ml | > 240 | | | | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | | {9}------------------------------------------------ | Characteristics<br>and Parameters | Subject Device | Predicate Device<br>(K200581) | Discussion | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Color | Fusion Colour | Blue | Different | | Design | • Single Use<br>• Non-sterile<br>• Powder-Free<br>• Ambidextrous | • Single Use<br>• Non-sterile<br>• Powder-Free<br>• Ambidextrous | Similar | | Sterility | Non-sterile | Non-sterile | Same | | Freedom from<br>holes | Meets ASTM D5151-19:<br>AQL 1.5 | Meets ASTM D5151-06(2015):<br>AQL 1.5 | Similar | | Length | Meets ASTM D6319-19:<br>XS: ≥ 220 mm<br>S: ≥ 220 mm<br>M: ≥ 230 mm<br>L: ≥ 230 mm<br>XL: ≥ 230 mm | Meets ASTM D6319-10(2015):<br>≥ 230 mm | Similar | | Characteristics<br>and Parameters | Subject Device | Predicate Device<br>(K200581) | Discussion | | Width | Meets ASTM D6319-19:<br>XS: 60 - 80 mm<br>S: 70 - 90 mm<br>M: 85 - 105 mm<br>L: 100 - 120 mm<br>XL: 110 - 130 mm | Meets ASTM D6319-10(2015):<br>XS: 60 - 80 mm<br>S: 70 - 90 mm<br>M: 85 - 105 mm<br>L: 100 - 120 mm<br>XL: 110 - 130 mm | Similar | | Thickness | Meets ASTM D6319-19:<br>Palm Thickness: ≥ 0.05 mm<br>Finger Thickness: ≥ 0.05 mm | Meets ASTM D6319-10(2015):<br>Palm Thickness: ≥ 0.05 mm<br>Finger Thickness: ≥ 0.05 mm | Similar | | Physical<br>Properties | Meets ASTM D6319-19:<br>Tensile Strength Before Aging: ≥ 14 MPa<br>Tensile Strength After Aging: ≥ 14 MPa<br>Ultimate Elongation Before Aging: ≥ 500 %<br>Ultimate Elongation After Aging: ≥ 400 % | Meets ASTM D6319-10(2015):<br>Tensile Strength Before Aging: ≥ 14 MPa<br>Tensile Strength After Aging: ≥ 14 MPa<br>Ultimate Elongation Before Aging: ≥ 500 %<br>Ultimate Elongation After Aging: ≥ 400 % | Similar | | Powder residual | Meets ASTM D6124-06 (2017):<br>Residual Powder: ≤ 2 mg per glove | Meets ASTM D6124-06 (2017):<br>Residual Powder: ≤ 2 mg per glove | Similar | | In vitro<br>Cytotoxicity<br>ISO 10993-5 | The neat extract was found to be cytotoxic | NA | Different | | Dermal<br>Sensitization<br>ISO 10993-10 | Under the conditions of the study, the<br>device is not a sensitizer | Under the conditions of the study, the device is<br>not a sensitizer | Similar | | Characteristics<br>and Parameters | Subject Device | Predicate Device<br>(K200581) | Discussion | | Acute Systemic<br>Toxicity Test<br>ISO 10993-11 | Under the conditions of this study, the<br>device showed no evidence of acute<br>systemic toxicity | Under the conditions of this study, the device<br>showed no evidence of acute systemic toxicity | Similar | | Primary Skin<br>Irritation<br>ISO 10993-23 | Under the conditions of the study, the<br>device is not an irritant | Under the conditions of the study, the device is<br>not an irritant | Similar | | Shelf-Life Expiry<br>ASTM D7160-16 | 3 years | 3 years | Identical | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ # SUMMARY OF NON-CLINICAL TESTING: Provided are the test methodology used to demonstrate whether the acceptance criteria in each respective standard. - . Biodegradability is not a medical claim and therefore was not reviewed by FDA. - . ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves - ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves ● - ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to . Permeation by Chemotherapy Drugs - . ISO 10993-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity - ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for skin sensitization . - . ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - . ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation - . ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves #### Physical Characteristics | Test Methodology/<br>Standards | Acceptance Criteria of the<br>Standards | Result Summary | | | | | | | | | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------|------------------------------|--------------------------------------------------------------------------------------------------|------------------------|--------------------------------------|----------------------------------------|--|----|------|------| | Dimensions<br><br>ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Size<br>XS | Length<br>(mm)<br>Min 220 | Width<br>(mm)<br>70 ± 10 | Meets ASTM D6319-19 requirements for length, and width. Similar to predicate device.<br><br>Size | Average<br>Length (mm) | Average<br>Width (mm) | | | | | | | | S | Min 220 | 80 ± 10 | | | | | | | | | | | M | Min 230 | 95 ± 10 | | | | | | | | | | | L | Min 230 | 110 ± 10 | | | | | | | | | | | XL | Min 230 | 120 ± 10 | | | | | | | | | | | XS | | | | 240 | 76 | | | | | | | | S | | | | 242 | 86 | | | | | | | | M | | | | 239 | 97 | | | | | | | | L | | | | 246 | 107 | | | | | | | | XL | | | | 245 | 114 | | | | | | | Dimensions<br><br>ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Thickness (mm)<br><br>Palm<br>Finger | | Minimum 0.05<br>Minimum 0.05 | Meets ASTM D6319-19 requirements for thickness.<br>Similar to predicate device | Size | Average<br>Palm<br>Thickness<br>(mm) | Average<br>Finger<br>Thickness<br>(mm) | | | | | | | | | | | | | | | XS | 0.05 | 0.08 | | | | | | | | | | | S | 0.05 | 0.08 | | | | | | | | | | | M | 0.06 | 0.08 | | | | | | | | | | | L | 0.06 | 0.08 | | | | | | XL | 0.06 | 0.08 | | | | | | {13}------------------------------------------------ | Physical Properties<br>ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | Parameter | Before<br>Aging | After<br>Aging | Meets ASTM D6319-19 requirements for tensile<br>strength and elongation at break before and after<br>accelerated aging. Similar to predicate device.<br><br><b>Before Age</b><br>Tensile Strength (MPa)<br>Average 35<br>Elongation at Break (%)<br>Average 565<br><br><b>After Age</b><br>Tensile Strength (MPa)<br>Average 36<br>Elongation at Break (%)<br>Average 469 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Tensile<br>Strength | Min<br>14 MPa | Min<br>14 MPa | | | | Ultimate<br>Elongation | Min<br>500% | Min<br>400% | | | Freedom from holes<br>ASTM D5151-19<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves<br>ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | AQL 2.5 | | | Meets ASTM D6319-19 and ASTM D5151-19<br>requirements of AQL 2.5. Similar to predicate<br>device.<br>Inspection Level G1<br>AQL Level 1.5<br>Although pass at AQL 1.5 quality level, it complies<br>with ASTM D6319-19 and ASTM D5151-19.<br>requirements of AQL 2.5 | | Powder residual<br>ASTM D6124-06(2017)<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves<br>ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Powder Free; ≤ 2 mg per glove | | | Meets ASTM D6319-19 and ASTM D6124-06<br>(2017) requirements for Powder Free; ≤ 2 mg per<br>glove. Similar to predicate device.<br>Average 0.14 mg/glove | {14}------------------------------------------------ | Chemotherapy Drugs<br>Permeation | | Chemotherapy Drug and<br>Concentration | Minimum<br>Breakthrough<br>Detection Time<br>in Minutes | |-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | ASTM D6978-05(2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | Under the conditions of the study, the<br>permeation is acceptable. | 5- Azacytidine, 25.0 mg/ml | > 240 | | | | Carboplatin, 10.0 mg/ml | > 240 | | | | Carmustine (3.3 mg/ml) | 12.1 | | | | Cisplatin (1.0 mg/ml) | > 240 | | | | Cyclophosphamide (20.0 mg/ml) | > 240 | | | | Dacarbazine (10.0 mg/ml) | > 240 | | | | Docetaxel, 10.0 mg/ml | > 240 | | | | Doxorubicin HCL (2.0 mg/ml) | > 240 | | | | Epirubicin HCL, 2.0 mg/ml | > 240 | | | | Etoposide (20.0 mg/ml) | > 240 | | | | Fluorouracil (50.0 mg/ml) | > 240 | | | | Gemcitabine, 38.0 mg/ml | > 240 | | | | Ifosfamide, 50.0 mg/ml | > 240 | | | | Irinotecan, 20.0 mg/ml | > 240 | | | | Methotrexate (25.0 mg/ml) | > 240 | | | | Mitomycin C (0.5 mg/ml) | > 240 | | | | Mitoxantrone, 2.0 mg/ml | > 240 | | | | Oxaliplatin, 5.0 mg/ml | > 240 | | | | Paclitaxel (6.0 mg/ml) | > 240 | | | | Thiotepa (10.0 mg/ml) | 37.8 | | | | Vincristine Sulfate (1.0 mg/ml) | > 240 | | | | Oncovin (1.0 mg/ml) | > 240 | | | | Vinorelbine, 10.0 mg/ml | > 240 | | | | Fentanyl Citrate, 100.0 mcg/2ml | > 240 | | | | Under the conditions of the study, the permeation is<br>acceptable. Similar to predicate devices.<br>Performance level of drugs between subject device<br>and predicate devices are comparable | | # Biocompatibility | Test Methodology/<br>Standards | Acceptance Criteria of the<br>Standards | Result Summary | |------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------| | In Vitro Cytotoxicity<br>ISO 10993-5:2009<br>Biological evaluation of<br>medical devices - Part 5:<br>Tests for in vitro<br>cytotoxicity | Under the conditions of the study, the<br>device is not cytotoxic | Under the conditions of the study, the device to be<br>found have cytotoxic effect | | Dermal Sensitization<br>ISO 10993-10:2021<br>Biological evaluation of<br>medical devices - Part 10:<br>Tests for skin sensitization | Under the conditions of the study, the<br>device is not a sensitizer | Under the conditions of the study, the device is not<br>a sensitizer. | {15}------------------------------------------------ | Primary Skin Irritation<br>ISO 10993-23:2021<br>Biological evaluation of<br>medical devices — Part 10:<br>Tests for irritation and skin<br>sensitization | Under the conditions of the study, the<br>device is not an irritant | Under the conditions of the study, the device is not<br>an irritant. | |----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Acute Systemic Toxicity<br>ISO 10993-11:2017<br>Biological evaluation of<br>medical devices —<br>Part 11: Tests for systemic<br>toxicity | Under the conditions of the study, the<br>device does not pose a toxicity<br>concern | Under the conditions of the study, there was no signs<br>of toxicity. | # CLINICAL PERFORMANCE DATA: Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate devices. # CONCLUSION: The conclusion drawn from the non-clinical tests demonstrates that the subject device herein mentioned is as safe, effective, and performs as well as or better than the legally marketed predicate device (K200581).