Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". October 7, 2022 Guang Dong Kingfa Sci. & Tech.Co., Ltd. Xiaoge Yu Director No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China Re: K222714 Trade/Device Name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: August 30, 2022 Received: September 8, 2022 Dear Xiaoge Yu: 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 mediation-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. Clarence W. Murray, III, 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K222714 Device Name Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs. Indications for Use (Describe) The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 17.2 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 13.9min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes Warning: Do not use with Carmustine and Thiotepa. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K222714 Device Name Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs Indications for Use (Describe) The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 65.3 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCl 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 58.3min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes Warning: Do not use with Carmustine and Thiotepa. 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. {5}------------------------------------------------ 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." {6}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K222714 Device Name Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs Indications for Use (Describe) The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Black Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 49.2 min. Cisplatin 1.0 mq/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Doxorubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 87.1min. Warning: Do not use with Carmustine and Thiotepa. 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. 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." {7}------------------------------------------------ ## 510(k) Summary – K222714 #### l. Submitter GUANG DONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn Preparation date: August. 30, 2022 #### II. Proposed Device | Device Trade Name | Nitrile Patient Examination Gloves Blue Tested For Use With<br>Chemotherapy Drugs | |--------------------|------------------------------------------------------------------------------------------| | | Nitrile Patient Examination Gloves Blue Violet Tested For Use<br>With Chemotherapy Drugs | | | Nitrile Patient Examination Gloves Black Tested For Use With<br>Chemotherapy Drugs | | Common name: | Patient Examination Glove (Tested For Use With Chemotherapy<br>Drugs) | | Regulation Number: | 21 CFR 880.6250 | | Regulatory Class: | Class I | | Product code: | LZA, LZC, OPJ, QDO | | Review Panel | General Hospital | #### III. Predicate Devices | 510(k) Number: | K213040 | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name: | Nitrile Patient Examination Gloves Blue Tested For Use With<br>Chemotherapy Drugs<br>Nitrile Patient Examination Gloves Blue Violet Tested For Use<br>With Chemotherapy Drugs<br>Nitrile Patient Examination Gloves Black Tested For Use With<br>Chemotherapy Drugs | | Common name: | Patient Examination Glove | | Classification: | Class I | {8}------------------------------------------------ Product Code: LZA, LZC,OPJ, QDO ### IV. Device description Powder-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, extra-small, medium, large, extralarge, extra-extra-large. Three colors are available for all size, includes blue, blue violet and black. The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019). ## V. Indication 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 per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The Nitrile Patient Examination Gloves Blue Tested Chemotherapy Drugs are as follows: - Bleomycin Sulfate 15 mg/ml >240 min. . - Busulfan 6 mg/ml >240 min. . - Carboplatin 10 mg/ml >240 min. . - Carmustine (BCNU) 3.3 mg/ml 17.2 min. . - Cisplatin 1.0 mg/ml >240 min. . - Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. ● - Cytarabine HCI 100 mg/ml >240 min. . - Dacarbazine (DTIC)10.0 mg/ml >240 min. . - Daunorubicin 5 mg/mL>240 min. . - Docetaxel 10.0 mg/ml >240 min . - Doxorubicin HCI 2.0 mg/ml >240 min. . - Epirubicin HCI 2.0 mg/ml >240 min. . - Etoposide (Toposar) 20.0 mg/ml >240 min. . {9}------------------------------------------------ K222714 - Fludarabine 25.0 mg/ml >240 min. . - Fluorouracil 50.0 mg/ml >240 min. . - Gemcitabine 38 mg/ml>240 min. . - ldarubicin 1 mg/ml >240 min. . - lfosfamide 50.0 mg/ml >240 min. . - Irinotecan 20.0 mg/ml >240 min. . - Mechlorethamine HCl 1.0 mq/ml>240 min. . - Melphalan 5 mg/ml >240 min. . - Methotrexate 25 mq/ml >240 min. . - Mitromycin C. 0.5 mg/ml >240 . - Mitoxantrone 2.0 mg/ml >240 min. . - Paclitaxel (Taxol) 6.0 mg/ml >240 min. . - Rituximab 10.0 mg/ml >240 min. . - Thiotepa 10.0 mq/ml 13.9min. . - Trisenox 1.0 mg/ml >240 min. . - Vincristine Sulfate 1.0 mg/ml >240 min. . - Fentanyl Citrate 100mcg/2ml >240 minutes . Warning: Do not use with Carmustine and Thiotepa. The Nitrile Patient Examination Gloves Blue Violet Tested Chemotherapy Drugs are as follows: - Bleomycin Sulfate 15 mg/ml >240 min. . - Busulfan 6 mg/ml >240 min. . - Carboplatin 10 mg/ml >240 min. . - Carmustine (BCNU) 3.3 mg/ml 65.3 min. . - Cisplatin 1.0 mg/ml >240 min. . - Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. . - Cytarabine HCI 100 mg/ml >240 min. . - Dacarbazine (DTIC)10.0 mg/ml >240 min. . - Daunorubicin 5 mq/mL>240 min. . - Docetaxel 10.0 mg/ml >240 min . - Doxorubicin HCI 2.0 mg/ml >240 min. . - Epirubicin HCI 2.0 mg/ml >240 min. . - Etoposide (Toposar) 20.0 mg/ml >240 min. . {10}------------------------------------------------ - Fludarabine 25.0 mg/ml >240 min. . - Fluorouracil 50.0 mg/ml >240 min. . - Gemcitabine 38 mg/ml>240 min. . - ldarubicin 1 mg/ml >240 min. . - lfosfamide 50.0 mg/ml >240 min. . - Irinotecan 20.0 mg/ml >240 min. . - Mechlorethamine HCI 1.0 mg/ml>240 min. . - Melphalan 5 mg/ml >240 min. . - Methotrexate 25 mq/ml >240 min. . - Mitromycin C. 0.5 mg/ml >240 . - Mitoxantrone 2.0 mg/ml >240 min. . - Paclitaxel (Taxol) 6.0 mg/ml >240 min. . - Rituximab 10.0 mg/ml >240 min. . - Thiotepa 10.0 mg/ml 58.3min. . - Trisenox 1.0 mg/ml >240 min. . - Vincristine Sulfate 1.0 mg/ml >240 min. . - Fentanyl Citrate 100mcg/2ml >240 minutes . Warning: Do not use with Carmustine and Thiotepa. The Nitrile Patient Examination Gloves Black Tested Chemotherapy Drugs are as follows: - Carmustine (BCNU) 3.3 mg/ml 49.2 min. . - Cisplatin 1.0 mg/ml >240 min. . - Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. . - Dacarbazine (DTIC)10.0 mg/ml >240 min. . - Doxorubicin HCI 2.0 mg/ml >240 min. . - Etoposide (Toposar) 20.0 mg/ml >240 min. . - Fluorouracil 50.0 mg/ml >240 min. . - Fentanyl Citrate 100mcg/2ml >240 minutes . - Paclitaxel (Taxol) 6.0 mg/ml >240 min. . - Thiotepa 10.0 mg/ml 87.1min. . Warning: Do not use with Carmustine and Thiotepa. {11}------------------------------------------------ # VI. Comparison of technological characteristics with the predicate devices | Item | Proposed device (K222714) | Predicate device (K213040) | Discussion | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Product name | Nitrile Patient Examination Gloves<br>Blue Tested For Use With Chemotherapy Drugs.<br>Nitrile Patient Examination Gloves<br>Blue Violet Tested For Use With Chemotherapy Drugs.<br>Nitrile Patient Examination Gloves<br>Black Tested For Use With Chemotherapy Drugs. | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs.<br>Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs.<br>Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs. | - | | Product Code | LZA, LZC,OPJ, QDO | LZA, LZC,OPJ, QDO | Same | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Classification | Class I | Class I | Same | | Powder free | Yes | Yes | Same | | Indication 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 as per ASTM D6978-05 | 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 | Same | | | | | | | | (Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | (Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | | | Main Material | Powder-Free Nitrile | Powder-Free Nitrile | Same | | Color | Blue, Blue violet, Black | Blue, Blue violet, Black | Same | | Size | x-small, small, medium,<br>large, x-large, XX-large | x-small, small, medium,<br>large, x-large, XX-large | Same | | Dimensions –<br>Length | Complies with ASTM<br>D6319-10<br>XS (220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br>XXL (230mm min) | Complies with ASTM<br>D6319-10<br>XS (220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br>XXL (230mm min) | Same | | Dimensions –<br>Width | Complies with ASTM<br>D6319-10<br>XS (70±10mm)<br>S (80±10mm)<br>M (95±10mm)<br>L (110±10mm)<br>XL (120±10mm)<br>XXL (≥120mm) | Complies with ASTM<br>D6319-10<br>XS (70±10mm)<br>S (80±10mm)<br>M (95±10mm)<br>L (110±10mm)<br>XL (120±10mm)<br>XXL (≥120mm) | Same | | Dimensions –<br>Thickness | Complies with:<br>ASTM D6319-10<br>Palm: 0.05mm min<br>Finger: 0.11mm min | Complies with:<br>ASTM D6319-10<br>Palm: 0.05mm min<br>Finger: 0.11mm min | Same | | Physical<br>Properties | Complies with:<br>ASTM D6319-10<br>minimum:<br>Tensile Strength:<br>Before Aging ≥14 MPa,<br>min.<br>After Aging ≥14 MPa,<br>min.<br>Elongation: | Complies with:<br>ASTM D6319-10<br>minimum:<br>Tensile Strength:<br>Before Aging ≥14 MPa,<br>min.<br>After Aging ≥14 MPa,<br>min.<br>Elongation: | Same | | | After Aging 400%, min. | After Aging 400%, min. | | | Freedom from<br>Holes | Complies with ASTM<br>D6319-10 and ASTM<br>D5151-06 G-1, AQL 1.5 | Complies with ASTM<br>D6319-10 and ASTM<br>D5151-06 G-1, AQL 1.5 | Same | | Residual<br>Powder | Complies with:<br>ASTM D6319-10<br><2mg per glove | Complies with:<br>ASTM D6319-10<br><2mg per glove | Same | | Contact<br>Durations | Limited <24 hours | Limited <24 hours | Same | | Biocompatibility | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction,<br>the test article is<br>considered cytotoxic, but<br>the acute systemic<br>toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the<br>test article is considered<br>cytotoxic, but the acute<br>systemic toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | Same | | Sterility | Non-sterile | Non-sterile | Same | | Rx Only or<br>OTC | Over the Counter | Over the Counter | Same | | Tested<br>Chemotherapy<br>Drugs | Nitrile Patient<br>Examination Gloves<br>Blue Colored<br>Tested For Use With<br>Chemotherapy Drugs<br>Bleomycin Sulfate 15<br>mg/ml >240 min.<br>Busulfan 6 mg/ml >240<br>min.<br>Carboplatin 10<br>mg/ml >240 min.<br>Carmustine (BCNU) 3.3<br>mg/ml 17.2 min.<br>Cisplatin 1.0<br>mg/ml >240 min | Nitrile Patient<br>Examination Gloves<br>Blue Colored<br>Tested For Use With<br>Chemotherapy Drugs<br>Bleomycin Sulfate 15<br>mg/ml >240 min.<br>NA<br>Carboplatin 10<br>mg/ml >240 min.<br>Carmustine (BCNU) 3.3<br>mg/ml 17.2 min.<br>Cisplatin 1.0 mg/ml >240<br>min | /<br>Similar¹ | ## Table 1 Comparison of Nitrile Examination Gloves {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | | |-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------| | Cytarabine HCI 100<br>mg/ml >240 min. | Cytarabine HCI 100<br>mg/ml >240 min. | | | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | | | Daunorubicin 5<br>mg/mL>240 min. | Daunorubicin 5<br>mg/mL>240 min. | | | Docetaxel 10.0 mg/ml<br>>240 min | Docetaxel 10.0 mg/ml<br>>240 min | | | Doxorubicin HCI 2.0<br>mg/ml >240 min. | Doxorubicin HCI 2.0<br>mg/ml >240 min. | | | Epirubicin HCI 2.0<br>mg/ml >240 min. | NA | | | Etoposide (Toposar)<br>20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0<br>mg/ml >240 min. | | | Fludarabine 25.0<br>mg/ml >240 min. | NA | | | Fluorouracil 50.0<br>mg/ml >240 min. | Fluorouracil 50.0<br>mg/ml >240 min. | | | Gemcitabine 38<br>mg/ml>240 min. | Gemcitabine 38<br>mg/ml>240 min. | | | Idarubicin 1 mg/ml >240<br>min. | Idarubicin 1 mg/ml >240<br>min. | | | Ifosfamide 50.0<br>mg/ml >240 min. | Ifosfamide 50.0<br>mg/ml >240 min. | | | Irinotecan 20.0 mg/ml<br>>240 min. | Irinotecan 20.0 mg/ml<br>>240 min. | | | Mechlorethamine HCI<br>1.0 mg/ml>240 min. | Mechlorethamine HCI 1.0<br>mg/ml>240 min. | | | Melphalan 5 mg/ml >240<br>min. | Melphalan 5 mg/ml >240<br>min. | | | Methotrexate 25<br>mg/ml >240 min. | Methotrexate 25<br>mg/ml >240 min. | | | Mitromycin C. 0.5<br>mg/ml >240 | Mitromycin C. 0.5<br>mg/ml >240 | | | Mitoxantrone 2.0 mg/ml | Mitoxantrone 2.0 mg/ml | | | | | | | >240 min. | >240 min. | | | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | | | Rituximab 10.0<br>mg/ml >240 min. | NA | | | Thiotepa 10.0 mg/ml<br>58.3min. | Thiotepa 10.0 mg/ml<br>58.3min. | | | Trisenox 1.0 mg/ml >240<br>min. | NA | | | Vincristine Sulfate 1.0<br>mg/ml >240 min. | Vincristine Sulfate 1.0<br>mg/ml >240 min. | | | Fentanyl Citrate<br>100mcg/2ml >240<br>minutes | NA | | | Nitrile Patient<br>Examination Gloves<br>Blue Violet Colored<br>Tested For Use With<br>Chemotherapy Drugs | Nitrile Patient<br>Examination Gloves<br>Blue Violet Colored<br>Tested For Use With<br>Chemotherapy Drugs | / | | Bleomycin Sulfate 15<br>mg/ml >240 min. | NA | Similar¹ | | Busulfan 6 mg/ml >240<br>min. | NA | | | Carboplatin 10<br>mg/ml >240 min. | NA | | | Carmustine (BCNU) 3.3<br>mg/ml 65.3 min. | Carmustine (BCNU) 3.3<br>mg/ml 65.3 min. | | | Cisplatin 1.0<br>mg/ml >240 min. | Cisplatin 1.0 mg/ml >240<br>min. | | | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | | | Cytarabine HCI 100<br>mg/ml >240 min. | NA | | | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | | | Daunorubicin 5<br>mg/ml >240 min. | NA | | | Docetaxel 10.0 mg/ml<br>>240 min | NA | | | Doxorubicin HCI 2.0<br>mg/ml >240 min. | Doxorubicin HCI 2.0<br>mg/ml >240 min. | | | Epirubicin HCI 2.0<br>mg/ml >240 min. | NA | | | Etoposide (Toposar)<br>20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0<br>mg/ml >240 min. | | | Fludarabine 25.0<br>mg/ml >240 min. | NA | | | Fluorouracil 50.0<br>mg/ml >240 min. | Fluorouracil 50.0<br>mg/ml >240 min. | | | Gemcitabine 38<br>mg/ml>240 min. | NA | | | Idarubicin 1 mg/ml >240<br>min. | NA | | | Ifosfamide 50.0<br>mg/ml >240 min. | NA | | | Irinotecan 20.0 mg/ml<br>>240 min. | NA | | | Mechlorethamine HCI<br>1.0 mg/ml>240 min. | NA | | | Melphalan 5 mg/ml >240<br>min. | NA | | | Methotrexate 25<br>mg/ml >240 min. | Methotrexate 25<br>mg/ml >240 min. | | | Mitromycin C. 0.5<br>mg/ml >240. | NA | | | Mitoxantrone 2.0 mg/ml<br>>240 min. | NA | | | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | | | Rituximab 10.0<br>mg/ml >240 min. | NA | | | Thiotepa 10.0 mg/ml<br>58.3min. | Thiotepa 10.0 mg/ml<br>58.3min. | | | Trisenox 1.0 mg/ml >240<br>min. | NA | | | Vincristine Sulfate 1.0<br>mg/ml >240 min. | NA | | | Fentanyl Citrate<br>100mcg/2ml >240 minutes | NA | | | Nitrile Patient<br>Examination Gloves<br>Black Colored<br>Tested For Use With<br>Chemotherapy Drugs | Nitrile Patient<br>Examination Gloves<br>Blue Violet Colored<br>Tested For Use With<br>Chemotherapy Drugs | / | | Cisplatin 1.0<br>mg/mL>240 min. | NA | Similar¹ | | Carmustine (BCNU) 3.3<br>mg/ml 49.2 min. | NA | | | Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 min. | NA | | | Dacarbazine (DTIC)10.0<br>mg/ml >240 min. | NA | | | Doxorubicin HCI 2.0<br>mg/ml >240 min. | NA | | | Etoposide (Toposar)<br>20.0 mg/ml >240 min. | NA | | | Fluorouracil 50.0<br>mg/ml >240 min. | NA | | | Paclitaxel (Taxol) 6.0<br>mg/ml >240 min. | NA | | | Thiotepa 10.0 mg/ml<br>87.1min. | NA | | | Fentanyl Citrate<br>100mcg/2ml >240<br>minutes | Fentanyl Citrate<br>100mcg/2ml >240<br>minutes | | {15}------------------------------------------------ {16}------------------------------------------------ {17}------------------------------------------------ 1 Add new kinds of the chemotherapy label claim to the previous cleared under K213040. The permeation testing was conducted per ASTM D6978-05 (Reapproved 2019) to support the addition of the labeling claim. ## VII. Non-Clinical Testing Non-clinical tests were leveraged from the predicate submission. Additional testing per {18}------------------------------------------------ ASTM D6978-05 (2019) was performed to support inclusion of additional chemotherapy drugs to the indications for use. | Test Methodology | Purpose | Acceptance Criteria | Results | | |------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------| | ASTM D6319 | Physical<br>Dimensions Test | Extra-Small:<br>Length: ≥ 220mm Width: 70±10 mm;<br>Small:<br>Length: ≥ 220mm Width: 80±10mm;<br>Medium:<br>Length: ≥ 230mm Width: 95±10mm<br>Large:<br>Length: ≥ 230mm Width: 110±10mm<br>Extra- Large:<br>Length: ≥ 230mm Width: 120±10mm<br>Extra- Extra- Large:<br>Length: ≥ 230mm Width: ≥120mm | Pass | | | | | Thickness (mm):<br>Finger:≥0.05<br>Palm: ≥0.08 | Pass | | | | Physical<br>properties | Before<br>Aging | | | | | | Tensile<br>Strength | ≥14MPa | Pass | | | | Ultimate<br>Elongation | ≥500% | | | | | After<br>Aging | | | | | | Tensile<br>Strength | ≥14MPa | Pass | | | | Ultimate<br>Elongation | ≥500% | | | ASTM D5151 | Freedom from<br>pinholes | Meet the requirements of ASTM<br>D5151Test for AQL 2.5 | Pass | | | ASTM D6124 | Powder Residue | Meet the requirements of ASTM<br>D6124< 2.0mg | Pass | | | ISO 10993-10 | To determine if<br>the finished device<br>material is an<br>irritant | Non-irritating | Under the<br>conditions of the<br>study not an<br>irritant/ Pass | | | ISO 10993-10 | To determine if<br>the finished device<br>material is a<br>sensitizer | Non- sensitizing | Under conditions<br>of the study, not a<br>sensitizer. / Pass | | | ISO 10993-11 | To determine if<br>the finished device<br>material extracts<br>pose a systemic<br>toxicity concern | Non-acute systemic toxicity | Under conditions<br>of the study, did<br>not show acute<br>systemic toxicity<br>in vivo / Pass | | Table 2 Summary of Non-Clinical Performance Testing {19}------------------------------------------------ - ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for ● Medical Application - ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ● - ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ● - . ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical Gloves - ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven - ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension - ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of ● Medical Gloves to Permeation by Chemotherapy Drugs - ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests ● For Irritation And Skin Sensitization. - ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for ● Systemic Toxicity # VIII. Clinical Testing No clinical study is included in this submission. ## IX. Conclusion The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device, Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs; Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs; Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs, are as safe, as effective, and performs as well as or better than the legally marketed predicate device (K213040).