Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 30, 2020 Kimberly Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075 Re: K202416 Trade/Device Name: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid. Kimtech Prizm Xtra Multi-Lavered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: November 25, 2020 Received: November 30, 2020 Dear Wava Truscott: 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 {1}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 and Part 809; 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, For: Elizabeth F. Claverie, MS 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}------------------------------------------------ #### 510(k) Number: K202416 = Device 1.) Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | Indications for Use (Describe):<br>CHEMICAL | CONCENTRATION | STANDARD LENGTH | |---------------------------------------------|----------------------------------------|-----------------| | Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. | | Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. | | Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. | | Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. | | Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | | Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | | Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | | Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. | | Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | | Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. | | Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | | Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. | | Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. | | Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. | | Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. | | Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. | | Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. | | Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. | | Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. | | Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. | | Fentanyl Citrate | 100mcg/2mL | >240 min. | | Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. | | Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. | Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X | Over-The-Counter (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 STAFFEMAILADDRESS BELOW® The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number" Form FDA 3881 (7/17) {3}------------------------------------------------ #### 510(k) Number: K202416 Device 2.) Trade Name: KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | Indications for Use (Describe): | | | |-----------------------------------------------------------------------------------------------------|----------------------------------------|-----------| | CHEMICAL | CONCENTRATION | XTRA | | Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. | | Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. | | Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. | | Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. | | Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | | Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | | Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | | Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. | | Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | | Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. | | Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | | Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. | | Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. | | Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. | | Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. | | Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. | | Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. | | Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. | | Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. | | Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. | | Fentanyl Citrate | 100mcg/2mL | >240 min. | | Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. | | Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. | | Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. respectively | | | Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X | Over-The-Counter (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 STAFFEMAILADDRESS 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) Number: K202416 510(k) Summary as required by 807.92(c) FDA Format: Traditional 510k Preparation Date: November 22, 2020 KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Trade Name: Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid KIMTECH™ PRIZMTM Xtra Multi-Layered Exam Glove Tested for use Trade Name: with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid #### 1. Submitter: | Company Name: | Kimberly-Clark Corporation | |-----------------|--------------------------------------------------------------------------------------------------------------------------------| | Address: | 1400 Holcomb Bridge Road<br>Roswell, GA 30076 | | Country: | United States | | General phone: | +1 770-587-8000 | | Contact Person: | Juan M. Marquez<br>Director, Regulatory Affairs<br>Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 | | E-mail: | Juan.M.Marquez@kcc.com | | Phone: | +1 678-352-6069 | | Fax: | +1 920-969-4863 | #### 2. Device information: Device Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid KIMTECH™ PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid Classification name: Per 21 CFR 807.92(a)2(2): Patient Examination Glove General Hospital and Personal Use Devices Synthetic Non-powdered Exam Glove Common name: Class: Class I (general controls) Product Codes: LZA, LZC, QDO {5}------------------------------------------------ # Indications for use: Intended Use: The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid. Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid KIMTECH™ PRIZM™M Multi-Layered Gloves: ASTM D6978-05 (2019): "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs" | CHEMICAL | CONCENTRATION | STANDARD Length | |--------------------------------------------------------------------------------------------------------|----------------------------------------|-----------------| | Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. | | Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. | | Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. | | Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. | | Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | | Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | | Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | | Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. | | Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | | Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. | | Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | | Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. | | Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. | | Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. | | Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. | | Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. | | Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. | | Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. | | Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. | | Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. | | Fentanyl Citrate | 100mcg/2mL | >240 min. | | Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. | | Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. | | Caution: Carmustine and Thiotepa have low penetration times of 47.5 min. and 38.2 min.<br>respectively | | | ## KIMTECH™ PRIZMTM Multi-Lavered Glove: Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 47.5 min. and 38.2 min. respectively {6}------------------------------------------------ # Indications for use: Intended Use: The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid. Trade Name: KIMTECHTM PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | CHEMICAL | CONCENTRATION | Xtra | |--------------------------------------------------------------------------------------------------------|----------------------------------------|-----------| | Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. | | Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. | | Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. | | Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. | | Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | | Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | | Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | | Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. | | Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | | Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. | | Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | | Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. | | Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. | | Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. | | Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. | | Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. | | Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. | | Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. | | Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. | | Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | | Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. | | Fentanyl Citrate | 100mcg/2mL | >240 min. | | Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. | | Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. | | Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min.<br>respectively | | | # KIMTECH™ PRIZM™ Xtra Multi-Layered Glove: Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 37.3 min. and 30.1 min. respectively {7}------------------------------------------------ # Subject Gloves Technological Characteristics Comparison Table # Predicate K200072 & K202416 Subject Gloves: Standard & Xtra Length | Attributes | Standard<br>Test | Predicate Device:<br>K200072 | Subject Glove 1<br>(standard length)<br>K202416 | Subject Glove 2<br>(Xtra-length)<br>K202416 | Comparison | |---------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | NA | Synthetic Examination<br>Glove | Synthetic<br>Examination<br>Glove | Synthetic<br>Examination<br>Glove | Same | | Intended Use | NA | The examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination<br>between patient and<br>examiner. | The examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | The examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | Same | | Base Material | NA | Synthetic: Nitrile | Synthetic:<br>Nitrile &<br>Polychloroprene | Synthetic:<br>Nitrile &<br>Polychloroprene | Similar:<br>Predicate and<br>both Subject<br>gloves are<br>Synthetic<br>Both Predicate<br>and Subject<br>gloves possess<br>nitrile<br>Subject gloves<br>also have<br>polychloroprene<br>in their<br>formulation<br>Does not<br>adversely<br>impact safety or<br>performance | | Color | NA | Purple | Dark Violet outer<br>surface<br>Deep Magenta inside<br>surface | Dark Violet outer<br>surface<br>Deep Magenta inside<br>surface | Different<br>Subject gloves<br>have different<br>inner & outer<br>surface colors.<br>Does not<br>adversely<br>impact safety or<br>performance | | Product code | NA | LZA, LZC, ODO | LZA, LZC, ODO | LZA, LZC, ODO | Same | | Attributes | Standard<br>Test | Predicate Device:<br>K200072 | Subject Glove 1<br>(standard length)<br>K202416 | Subject Glove 2<br>(Xtra-length)<br>K202416 | Comparison | | Sterile vs. non-<br>sterile | NA | Non-sterile | Non-sterile | Non-sterile | Same | | Prescription or<br>OTC | NA | OTC | OTC | OTC | Same | | Single Use-<br>Disposable | NA | Yes | Yes | Yes | Same | | Indications for<br>use (summary) | ASTM<br>D1678-05 | Glove was Tested<br>for use with<br>chemotherapy<br>drugs, the Opioid<br>Fentanyl Citrate,<br>simulated Gastric<br>acid, and Fentanyl<br>in Gastric Acid | Glove was Tested for<br>use with<br>chemotherapy drugs,<br>the Opioid Fentanyl<br>Citrate, simulated<br>Gastric acid, and<br>Fentanyl in Gastric<br>Acid | Glove was Tested for<br>use with<br>chemotherapy drugs,<br>the Opioid Fentanyl<br>Citrate, simulated<br>Gastric acid, and<br>Fentanyl in Gastric<br>Acid | Same:<br>Test Method<br>Same:<br>Fentanyl<br>Citrate,<br>simulated<br>Gastric Acid<br>and Fentanyl in<br>Gastric Acid<br>Similar:<br>Chemotherapy<br>Chemicals<br>tested<br>(see below) | | Chemicals<br>Tested | ASTM<br>D1678-05 | Chemotherapy<br>drugs tested:<br>Carmustine<br>(BCNU)<br>Cisplatin,<br>Cyclophosphamide<br>(Cytoxan),<br>Dacarbazine<br>(DTIC)<br>Doxorubicin<br>Hydrochloride,<br>Etoposide<br>(Toposar)<br>Fluorouracil,<br>Methotrexate<br>Paclitaxel (Taxol),<br>Thiotepa<br>Vincristine Sulfate | Chemotherapy<br>drugs tested:<br>Cabazitaxel<br>Capecitabine<br>Carmustine<br>Cisplatin,<br>Cyclophosphamide<br>Dacarbazine<br>Doxorubicin HCL<br>Eribulin Mesylate<br>Etoposide<br>Floxuridine<br>Fluorouracil<br>Ifosfamide,<br>Lenvatinib<br>Mitoxantrone<br>Paclitaxel,<br>Permetrexed<br>Sorafenib Tosylate<br>Tamoxifen<br>Thiotepa<br>Vinblastine Sulfate<br>Vincristine Sulfate<br>Vinorelbine | Chemotherapy<br>drugs tested:<br>Cabazitaxel<br>Capecitabine<br>Carmustine<br>Cisplatin,<br>Cyclophosphamide<br>Dacarbazine<br>Doxorubicin HCL<br>Eribulin Mesylate<br>Etoposide<br>Floxuridine<br>Fluorouracil<br>Ifosfamide,<br>Lenvatinib<br>Mitoxantrone<br>Paclitaxel,<br>Permetrexed<br>Sorafenib Tosylate<br>Tamoxifen<br>Thiotepa<br>Vinblastine Sulfate<br>Vincristine Sulfate<br>Vinorelbine | Similar:<br>Some<br>chemotherapy<br>drugs are<br>different | | Attributes | Standard<br>Test | Predicate Device:<br>K200072 | Subject Glove 1<br>(standard length)<br>K202416 | Subject Glove 2<br>(Xtra-length)<br>K202416 | Comparison | | Caution/<br>Warning<br>Statements | NA | In Addition: Fentanyl<br>Citrate simulated<br>Gastric Acid,<br>Fentanyl in Gastric<br>Acid<br><br>Note: Carmustine<br>and Thiotepa have<br>extremely low<br>permeation times<br>of 3.6 &15.9 min.<br>respectively.<br><br>WARNING: Do<br>Not Use With:<br>Carmustine,<br>Thiotepa | In Addition: Fentanyl<br>Citrate simulated<br>Gastric Acid,<br>Fentanyl in Gastric<br>Acid<br><br>Caution:<br>Carmustine and<br>Thiotepa have low<br>permeation times<br>below 60<br>minutes at 47.5<br>min and 38.2 min.<br>respectively | In Addition: Fentanyl<br>Citrate simulated<br>Gastric Acid,<br>Fentanyl in Gastric<br>Acid<br><br>Caution:<br>Carmustine and<br>Thiotepa have low<br>permeation times<br>below 60<br>minutes at 37.3<br>min and 30.1 min.<br>respectively | Different<br>The predicate<br>has a Warning<br>while both<br>Subject Glove 1<br>and 2 have<br>Caution<br>statement | | Dimensions:<br>Overall Length | ASTM D6319<br>Minimum:<br>230mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same | | Dimensions:<br>Overall Width | ASTM D6319<br>Minimum: 110<br>+ 10mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same | | Dimensions:<br>Palm &<br>Finger<br>Thickness | ASTM D6319<br>Minimum:<br>Palm: 0.05mm<br>Finger:<br>0.05mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same | | Tensile<br>strength:<br>Before & After<br>Aging | ASTM D6319<br>Minimum<br>Before: 14MPa<br>After: 14MPa | Complies both<br>before and after<br>accelerated aging | Complies both<br>before and after<br>accelerated aging | Complies both<br>before and after<br>accelerated aging | Same | | Ultimate<br>elongation<br>Before &<br>After aging | ASTM D6319<br>Minimum:<br>Before: 500%<br>After:<br>400% | Complies both before<br>and after accelerated<br>aging | Complies both before<br>and after accelerated<br>aging | Complies both before<br>and after accelerated<br>aging | Same | | Attributes | Standard Test | Predicate Device:<br>K200072 | Subject Glove 1<br>(standard length)<br>K202416 | Subject Glove 2<br>(Xtra-length)<br>K202416 | Comparison | | Freedom from holes | ASTM D6319<br>G1,<br>AQL 2.5<br>7 Accept<br>8 Reject | Pass | Pass | Pass | Same | | Powder Free | ASTM 6319<br>Maximum<br><2mg/glove | Pass | Pass | Pass | Same | | Bio-<br>compatibility | ISO 10993-11<br>Systemic Toxicity Test | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Same | | | ISO 10993-10<br>Primary Skin Irritation on Rabbits | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Same | | | ISO 10993-10<br>Magnusson & Kligman<br>Guinea pig Maximization | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Same | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications. The test results demonstrated that the proposed devices did meet the performance criteria as specified utilizing the following test method standards and specifications: {11}------------------------------------------------ | Summary of Non-Clinical Performance Tests | | |-----------------------------------------------------------------------------------------------------------------------------------------|------| | ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical<br>Application | Pass | | ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized<br>Rubber and Thermoplastic Elastomers-Tension | Pass | | ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-<br>Deterioration in an Air Oven | Pass | | ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions | Pass | | ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in<br>Medical Gloves | Pass | | ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on<br>Medical Gloves | Pass | | ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy Drugs | Pass | | ISO 2859 Sampling Procedures and Tables for Inspection by Attributes | Pass | | ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and<br>Sensitization | Pass | | ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity | Pass | Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject devices are as safe, as effective, and performs as well as or better than the legally marketed device.