Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 18, 2022 Luliang Hongruida Health Protection Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, California 91710 Re: K213440 Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), 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 Dated: December 23, 2021 Received: January 10, 2022 Dear Kathy Liu: 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. Clarence W. Murray, III, PhD 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) K213440 Device Name Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Indications for Use (Describe) Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results. The following chemicals have been tested with these gloves: | For Blue gloves: | | |---------------------------------------------|-----------------------| | Chemotherapy Drug | Minimum BDT (Minutes) | | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | | Busulfan 6mg/ml (6,000 ppm) | >240 | | Carboplatin 10mg/ml (10,000 ppm) | >240 | | Carmustine 3.3 mg/ml (3,300 ppm) | 25.5 | | Chloroquine 50mg/ml (50,000ppm) | >240 | | Cisplatin 1mg/ml (1,000 ppm) | >240 | | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | | Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | | Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | | Fluorouracil, 50mg/ml (50,000ppm) | >240 | | Gemcitabine, 38mg/ml (38,000ppm) | >240 | | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | | Ifosfamide, 50mg/ml (50,000ppm) | >240 | | Irinotecan, 20mg/ml (20,000ppm) | >240 | | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | | Melphalan, 5mg/ml (5,000ppm) | >240 | | Methotrexate, 25mg/ml (25,000ppm) | >240 | | Mitomycin, 0.5mg/ml (500ppm) | >240 | | Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | | Oxaliplatin, 5mg/ml (5,000ppm) | >240 | | Paclitaxel, 6mg/ml (6,000ppm) | >240 | | Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | | Retrovir, 10mg/ml (10,000ppm) | >240 | | Rituximab, 10mg/ml (10,000ppm) | >240 | | Thiotepa, 10mg/ml (10,000ppm) | 66.8 | | Topotecan, 1mg/ml (1,000ppm) | >240 | | Trisenox, 1mg/ml (1,000ppm) | >240 | | Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | {3}------------------------------------------------ Vincristine Sulfate, 1mg/ml (1,000ppm) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes | For Purple-Blue gloves: | | |-----------------------------------------------------------------------------|-----------------------| | Chemotherapy Drug | Minimum BDT (Minutes) | | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | | Busulfan 6mg/ml (6,000 ppm) | >240 | | Carboplatin 10mg/ml (10,000 ppm) | >240 | | Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 | | Chloroquine 50mg/ml (50,000ppm) | >240 | | Cisplatin 1mg/ml (1,000 ppm) | >240 | | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | | Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | | Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | | Fluorouracil, 50mg/ml (50,000ppm) | >240 | | Gemcitabine, 38mg/ml (38,000ppm) | >240 | | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | | Ifosfamide, 50mg/ml (50,000ppm) | >240 | | Irinotecan, 20mg/ml (20,000ppm) | >240 | | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | | Melphalan, 5mg/ml (5,000ppm) | >240 | | Methotrexate, 25mg/ml (25,000ppm) | >240 | | Mitomycin, 0.5mg/ml (500ppm) | >240 | | Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | | Oxaliplatin, 5mg/ml (5,000ppm) | >240 | | Paclitaxel, 6mg/ml (6,000ppm) | >240 | | Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | | Retrovir, 10mg/ml (10,000ppm) | >240 | | Rituximab, 10mg/ml (10,000ppm) | >240 | | Thiotepa, 10mg/ml (10,000ppm) | 36.3 | | Topotecan, 1mg/ml (1,000ppm) | >240 | | Trisenox, 1mg/ml (1,000ppm) | >240 | | Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | | Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | | * Please note that the following drugs have extremely low permeation times: | | | Carmustine: 21.2 minutes, Thiotepa: 36.3 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. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China ## 510(K) SUMMARY The assigned 510(K) numbers: K213440 Date Prepared: December 23, 2021 ## 1. Owner's Identification: Mr. Zhang Guocai Luliang Hongruida Health Protection Technology Co., Ltd. Zhaokua Area, Luliang Industrial Zone, Quiing City, Yunnan Province, 655606 China Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com ## 2. Name of the Device: Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Common Name: Examination Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA LZC Classification Panel: General Hospital Device Class: Class I ## 3. Predicate Device Information: Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600) ## 4. Device Description: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes—Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019). {6}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China #### 510(K) SUMMARY ### 5. Indications for Use: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves: Blue øloves | Blue gloves | | |---------------------------------------------|-----------------------| | Chemotherapy Drug | Minimum BDT (Minutes) | | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | | Busulfan 6mg/ml (6,000 ppm) | >240 | | Carboplatin 10mg/ml (10,000 ppm) | >240 | | Carmustine 3.3 mg/ml (3,300 ppm) | 25.5 | | Chloroquine 50mg/ml (50,000ppm) | >240 | | Cisplatin 1mg/ml (1,000 ppm) | >240 | | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | | Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | | Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | | Fluorouracil, 50mg/ml (50,000ppm) | >240 | | Gemcitabine, 38mg/ml (38,000ppm) | >240 | | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | | Ifosfamide, 50mg/ml (50,000ppm) | >240 | | Irinotecan, 20mg/ml (20,000ppm) | >240 | | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | | Melphalan, 5mg/ml (5,000ppm) | >240 | | Methotrexate, 25mg/ml (25,000ppm) | >240 | | Mitomycin, 0.5mg/ml (500ppm) | >240 | | Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | | Oxaliplatin, 5mg/ml (5,000ppm) | >240 | | Paclitaxel, 6mg/ml (6,000ppm) | >240 | | Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | | Retrovir, 10mg/ml (10,000ppm) | >240 | | Rituximab, 10mg/ml (10,000ppm) | >240 | | Thiotepa, 10mg/ml (10,000ppm) | 66.8 | | Topotecan, 1mg/ml (1,000ppm) | >240 | {7}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China ### 510(K) SUMMARY | Trisenox, 1mg/ml (1,000ppm) | >240 | |-----------------------------------------|------| | Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | | Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | * Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes #### Purple-Blue gloves | Chemotherapy Drug | Minimum BDT (Minutes) | |---------------------------------------------|-----------------------| | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | | Busulfan 6mg/ml (6,000 ppm) | >240 | | Carboplatin 10mg/ml (10,000 ppm) | >240 | | Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 | | Chloroquine 50mg/ml (50,000ppm) | >240 | | Cisplatin 1mg/ml (1,000 ppm) | >240 | | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | | Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | | Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | | Fluorouracil, 50mg/ml (50,000ppm) | >240 | | Gemcitabine, 38mg/ml (38,000ppm) | >240 | | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | | Ifosfamide, 50mg/ml (50,000ppm) | >240 | | Irinotecan, 20mg/ml (20,000ppm) | >240 | | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | | Melphalan, 5mg/ml (5,000ppm) | >240 | | Methotrexate, 25mg/ml (25,000ppm) | >240 | | Mitomycin, 0.5mg/ml (500ppm) | >240 | | Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | | Oxaliplatin, 5mg/ml (5,000ppm) | >240 | | Paclitaxel, 6mg/ml (6,000ppm) | >240 | | Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | | Retrovir, 10mg/ml (10,000ppm) | >240 | | Rituximab, 10mg/ml (10,000ppm) | >240 | | Thiotepa, 10mg/ml (10,000ppm) | 36.3 | | Topotecan, 1mg/ml (1,000ppm) | >240 | | Trisenox, 1mg/ml (1,000ppm) | >240 | | Velcade (Bortezomib) , 1mg/ml (1,000ppm) | >240 | | Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | * Please note that the following drugs have extremely low permeation times: Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes {8}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China ### 510(K) SUMMARY ## 6. Comnarison of Subiect Device and Predicate Device: The proposed device will be known as Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs. The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices. | | Proposed Device<br>K213440 | Predicate Device<br>K182600 | Remark | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Trade Name | Powder Free Nitrile<br>Examination Gloves<br>(Blue, Purple-Blue),<br>Tested for Use with<br>Chemotherapy Drugs | Powder Free Nitrile<br>Examination Gloves,<br>Tested for Use with<br>Chemotherapy Drugs<br>(Blue) | Similar | | Product Code | LZA, LZC | LZA, LZC | Same | | Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Class | I | I | Same | | Indications for Use | Powder Free Nitrile<br>Examination Gloves (Blue,<br>Purple-Blue), Tested for Use<br>with Chemotherapy Drugs is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and examiner. | Powder Free Nitrile<br>Examination Gloves, Tested for<br>Use with Chemotherapy Drugs<br>(Blue) is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner. | Same | | Powder or Powder<br>Free | Powder Free | Powder Free | Same | | Design Feature | Ambidextrous | Ambidextrous | Same | | Color | Blue, Purple-Blue | Blue | Similar | | Labeling<br>Information | Single-use, powder free<br>glove size, quantity,<br>Nitrile Examination<br>Gloves, Non Sterile | Single-use, powder free glove<br>size, quantity, Nitrile<br>Examination Gloves, Non<br>Sterile | Same | | Chemotherapy Drug<br>Permeation Claim | See below comparison<br>table | See below comparison table | Same | General Comparison Table: #### Dimensions and Performance Comparison Table: | Technological | Proposed Device | Predicate Device | Remark | |---------------|-----------------|------------------|--------| |---------------|-----------------|------------------|--------| {9}------------------------------------------------ | Characteristics | K213440 | K182600 | | |------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------| | Length | Minimum 230mm | Minimum 230mm | Same | | Palm Width (size) (mm) | | | | | XS | 70±10 | 70±10 | Same | | S | 80±10 | 80±10 | Same | | M | 95±10 | 95±10 | Same | | L | 110±10 | 110±10 | Same | | XL | 120±10 | 120±10 | Same | | XXL | 130±10 | 130±10 | Same | | Thickness(mm) | | | | | Finger | Minimum 0.05 | Minimum 0.05 | Same | | Palm | Minimum 0.05 | Minimum 0.05 | Same | | Tensile Strength,<br>Before Aging | 14MPa, min | 14MPa, min | Same | | Ultimate Elongation,<br>Before Aging | 500%, min | 500%, min | Same | | Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 14MPa, min | Same | | Ultimate Elongation,<br>After Accelerated<br>Aging | 400%, min | 400%, min | Same | | Freedom from holes | In accordance with<br>ASTM D 5151-19,<br>following ASTM D6319- 19,<br>G-I, AQL 2.5 | In accordance with<br>ASTM D 5151-19,<br>following ASTM D6319- 19,<br>G-I, AQL 2.5 | Same | | Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same | | 10993-10:2010 Skin<br>Irritation Study | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | Same | | 10993-10:2010<br>Maximization<br>Sensitization Study | Under the conditions of the<br>study, not a sensitizer | Under the conditions of the<br>study, not a sensitizer | Same | | 10993-5:2009<br>Cytotoxicity Test | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity | Under the conditions of<br>this study, no cytotoxic<br>potential | Same | | ISO 10993 Part 11<br>Systemic toxicity | Under the conditions of this<br>study, there was no evidence of<br>systemic toxicity. | / | Different | {10}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China # 510(K) SUMMARY | Chemotherapy Permeation Comparison: | | | | | |---------------------------------------------|----------------------------|-----------------------------|-------------|---------| | Tested Chemotherapy Drug and | Minimum BDT (Minutes) | | | | | Concentration | Proposed Device<br>K213440 | Predicate Device<br>K182600 | | Remark | | | | Blue | Purple-Blue | | | Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 | Same | | Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 | Same | | Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | Same | | Carmustine 3.3 mg/ml (3,300 ppm) | 7.0 | 25.5 | 21.2 | Similar | | Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same | | Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same | | Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same | | Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | Same | | Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | Same | | Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same | | Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 | Same | | Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same | | Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same | | Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same | | Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same | | Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 | Same | | Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same | | Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | Same | | Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | | Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same | | Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | Same | | Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | | Melphalan, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same | | Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same | | Mitomycin, 0.5mg/ml (500ppm) | >240 | >240 | >240 | Same | | Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | Same | | Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same | | Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same | | Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same | | Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same | | Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same | | Thiotepa, 10mg/ml (10,000ppm) | 23.0 | 66.8 | 36.3 | Similar | | Topotecan, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | | Trisenox, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | | Velcade (Bortezomib) , 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | | Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same | {11}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China ## 510(K) SUMMARY # 7. Non-Clinical Performance Data Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: - ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization. - . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity - ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for . systemic toxicity - ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on . Medical Gloves - ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. - ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application. - ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves ● to Permeation by Chemotherapy Drugs. | Test method | Purpose | Acceptance Criteria | Results | |-------------------------------|----------------------------------------------|--------------------------------------------|--------------------| | ASTM D6319- 19 | Length | Minimum 230mm | All size ≥230 | | ASTM D6319- 19 | Palm Width | XS: 70±10mm | 77-78mm | | | | S: 80±10mm | 86-88 mm | | | | M:95±10mm | 96 -98mm | | | | L:110±10mm | 108-110 mm | | | | XL: 120±10mm | 116-117 mm | | | | XXL: 130±10mm | 126-127 mm | | ASTM D6319- 19 | Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | ≥0.05mm<br>≥0.05mm | | ASTM D6319-19<br>ASTN D412-16 | Tensile Strength, Before<br>Aging | 14MPa, min | ≥14 MPa | | ASTM D6319-19<br>ASTN D412-16 | Tensile Strength, After<br>Accelerated Aging | 14MPa, min | ≥14 MPa | {12}------------------------------------------------ Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China | 510(K) SUMMARY | | | | |----------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | ASTM D6319-19<br>ASTN D412-16 | Ultimate Elongation,<br>Before Aging | 500%, min | ≥500% | | ASTM D6319-19<br>ASTN D412-16 | Ultimate Elongation,<br>After Accelerated Aging | 400%, min | ≥400% | | ASTM D 5151-19<br>ASTM D6319- 19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5<br>requirements | | ASTM D 6124-06(2017)<br>ASTM D6319- 19 | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements | | ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of<br>the study, not an irritant | Under the conditions of<br>the study, not an irritant | | ISO 10993-10:2010 | Maximization<br>Sensitization Study | Under the conditions of<br>the study, not a sensitizer | Under the conditions of<br>the study, not a sensitizer | | ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of<br>this study, the test article<br>extract showed potential<br>toxicity | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity | | ISO 10993-11:2017 | Systemic toxicity | Under the conditions of<br>this study, there was no<br>evidence of systemic<br>toxicity. | Under the conditions of this<br>study, there was no evidence<br>of systemic toxicity. | | ASTM D6978-05 (2019) | Tested for Use with<br>Chemotherapy Drugs | / | Details refer to the above 5.0<br>result | #### 510/K) SUMMARV # 8. Clinical Performance Data N/A # 9. Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.