Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. November 22, 2020 Molnlycke Health Care, US LLC Leonard Stewart Regulatory Affairs Specialist 5445 Triangle Parkway, Suite 400 Peachtree Corners, Georgia 30092 Re: K202090 Trade/Device Name: Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents; Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents; Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents; Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents; Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents; Biogel® PI Ultra Touch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents: Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC Dated: July 24, 2020 Received: July 28, 2020 Dear Leonard Stewart: 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. {1}------------------------------------------------ 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. 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 (OS) 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. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202090 Device Name Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents Indications for Use (Describe) The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs [continued on next page] | 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 {3}------------------------------------------------ | Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) | |----------------------------------------|-------------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 12.1 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 14.1 | | Vincristine Sulfate 1 mg/ml | >240 | {4}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K202090 Device Name Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotheray agents #### Indications for Use (Describe) The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {5}------------------------------------------------ | Drug and Concentration | Breakthrough detection time in minutes<br>(0.01µg/cm²/mins) | |-------------------------------------|-------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 11.7 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 15.6 | | Vincristine Sulfate 1 mg/ml | >240 | {6}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202090 Device Name Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents Indications for Use (Describe) The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {7}------------------------------------------------ | Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) | |-------------------------------------|-------------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 14.0 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 23.5 | | Vincristine Sulfate 1 mg/ml | >240 | {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202090 Device Name Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents Indications for Use (Describe) Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {9}------------------------------------------------ | Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) | |----------------------------------------|-------------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 5.3 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 13.1 | | Vincristine Sulfate 1 mg/ml | >240 | {10}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K202090 #### Device Name Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents Indications for Use (Describe) The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {11}------------------------------------------------ | Drug and Concentration | Breakthrough detection time in minutes (0.01µg/cm²/mins) | |-------------------------------------|----------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 13.2 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 22.3 | | Vincristine Sulfate 1 mg/ml | >240 | {12}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K202090 #### Device Name Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents #### Indications for Use (Describe) The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {13}------------------------------------------------ | Drug and Concentration | Breakthrough detection time in minutes<br>(0.01µg/cm²/mins) | |-------------------------------------|-------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 14.3 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 26.8 | | Vincristine Sulfate 1 mg/ml | >240 | {14}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K202090 #### Device Name Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents #### Indications for Use (Describe) The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: [continued on next page] | 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 {15}------------------------------------------------ | Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) | |----------------------------------------|-------------------------------------------------------------------| | Bleomycin 15 mg/ml | >240 | | Busulfan 6 mg/ml | >240 | | Carmustine 3.3 mg/ml | 15.2 | | Cisplatin 1 mg/ml | >240 | | Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 | | Cytarabine HCL 100 mg/ml | >240 | | Dacarbazine (DTIC) 10 mg/ml | >240 | | Doxorubicin HCL 2 mg/ml | >240 | | Ellence 2 mg/ml | >240 | | Etoposide (Toposar) 20 mg/ml | >240 | | Fludarabine 25 mg/ml | >240 | | Fluorouracil 50 mg/ml | >240 | | Idarubicin 1 mg/ml | >240 | | Ifosfamide 50 mg/ml | >240 | | Mechlorethamine HCl 1 mg/ml | >240 | | Melphalan 5 mg/ml | >240 | | Methotrexate 25 mg/ml | >240 | | Mitomycin C 0.5 mg/ml | >240 | | Mitoxantrone 2 mg/ml | >240 | | Paclitaxel (Taxol) 6 mg/ml | >240 | | Paraplatin 10 mg/ml | >240 | | Rituximab 10 mg/ml | >240 | | Thiotepa 10 mg/ml | 17.8 | | Vincristine Sulfate 1 mg/ml | >240 |