Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

K162982 · Medline Industries, Inc. · LZA · Feb 27, 2017 · General Hospital

Device Facts

• Record ID: K162982
• Device Name: Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
• Applicant: Medline Industries, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Feb 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination glove; features inner coating of colloidal oatmeal USP; beaded cuff design. Used in clinical settings by healthcare examiners to prevent cross-contamination between patient and examiner. Input: physical barrier requirement during patient examination or chemotherapy drug handling. Output: physical protection for the examiner's hand. Device provides barrier protection against biological contaminants and specific chemotherapy agents. Healthcare providers use the glove as a standard personal protective equipment (PPE) item; output affects clinical decision-making by enabling safe handling of hazardous chemotherapy drugs and reducing infection transmission risk. Benefits include hand protection and skin comfort via colloidal oatmeal.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility evaluated per ISO 10993-10 (skin irritation, sensitization). Physical performance tested per ASTM D6319-10. Chemotherapy drug permeation tested per ASTM D6978-05, with breakthrough times reported for 38 drugs.

Technological Characteristics

Nitrile material with colloidal oatmeal USP inner coating. Ambidextrous, beaded cuff, white color. Complies with ASTM D6319-10 (physical properties, dimensions, residual powder) and ASTM D5151-06 (freedom from holes). Chemotherapy resistance tested per ASTM D6978-05. Non-sterile, single-use.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

Regulatory Classification

Identification

A non-powdered patient 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K160562)

Reference Devices

• Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Tested for Use with Chemotherapy Drugs (K151750)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2017

Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060

Re: K162982

Trade/Device Name: Medline Nitrile Powder-free Examination Glove With Colloidal Oatmeal USP (tested For Use With Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 31, 2017 Received: January 31, 2017

Dear Jennifer Mason:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runne DDS, MA

For Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K162982

#### Device Name

Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

Indications for Use (Describe)

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 as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Blenoxane (Bleomycin) 15 mg/ml >240 minutes Bortezomib 1 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 11.9 minutes Cetuximab (Erbitux) 2 mg/ml >240 minutes Cisplatin 1.0 mg.ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Daunorubicin 5 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Ellence 2 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38 mg/ml >240 minutes Idarubicin 1 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 20.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5 mg/ml >240 minutes Methotrexate 25 mg/ml >240 minutes Methotrexate 50 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10 mg/ml >240 minutes Pemetrexed Disodium 25 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10 mg/ml >240 minutes Thiotepa 10.0 mg/ml 18.6 minutes Trisonex 0.1 mg/ml >240 minutes Vidaza (5-Azacytidine) 25 mg/ml >240 minutes Vinblastine 1 mg/ml >240 minutes

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Vinorelbine 10 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) (3.3 mg/ml) 11.9 minutes Thiotepa (10.0 mg/ml) 18.6 minutes

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/4/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. A gray bar is visible on the right side of the image.

# K162982 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

### Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

Registration Number: 1417592

### Contact Person

Jennifer Mason Senior Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

Summary Preparation Date February 27, 2017

Type of 510(k) Submission Traditional

### Device Name / Classification

Name of Device: Patient Examination Glove (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulation #: 21 CFR 880.6250

### Predicate Device

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs K160562

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Image /page/5/Picture/0 description: The image features the logo for Medline, a medical supply company. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white cross. The cross is oriented diagonally, with its top point extending upwards and to the right. The background is a solid dark blue color, providing a strong contrast to the white text and cross. A small gray rectangle is visible in the upper right corner of the image.

e Medline Place

#### Reference Device

Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Tested for Use with Chemotherapy Drugs K151750

#### Device Description

The Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, white colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.

The gloves are designed and manufactured per ASTM D6319-10 standard and tested for use with chemotherapy drugs per ASTM D6978-05 (reapproved 2013).

### Indications 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 as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug Tested | Breakthrough Time<br>(in minutes) |
|---------------------------------------|-----------------------------------|
| Blenoxane 15 mg/ml | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 11.9 |
| Cetuximab (Eributux) 2 mg/ml | >240 |
| Cisplatin 1.0 mg.ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC)10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue background. To the right of the word is a white star-like symbol with four points. The background is a solid blue color, providing a stark contrast to the white text and symbol.

| Fluorouracil 50.0 mg/ml | >240 |
|---------------------------------|------|
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50.0 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Methotrexate 50 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2.0 mg/ml | >240 |
| Oxaliplatin 5 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Pemetrexed Disodium 25 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 18.6 |
| Trisonex 0.1 mg/ml | >240 |
| Vidaza (5-Azacytidine) 25 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| | |

Please note that the following drugs have extremely low permeation times:

Carmustine (BCNU) (3.3 mg/ml) 11.9 minutes

Thiotepa (10.0 mg/ml) 18.6 minutes

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Image /page/7/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters stacked on top of each other. To the right of the word is a white starburst symbol. The background of the logo is a solid blue color.

## Summary of Technological Characteristics

### TABLE 1: Comparison of Proposed and Predicate Devices

| Device<br>Characteristic | Proposed<br>Device | Predicate<br>Device | Reference<br>Device | Comparison<br>Analysis |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Product Name | Medline Nitrile<br>Powder-Free<br>Examination Glove<br>with Colloidal<br>Oatmeal USP (Tested<br>for Use with<br>Chemotherapy Drugs) | Nitrile Powder Free<br>Examination Glove<br>with Colloidal<br>Oatmeal USP Tested<br>for Use with<br>Chemotherapy Drugs | Powder Free Nitrile<br>Patient Examination<br>Glove, White<br>Colored, Non Sterile.<br>Tested for Use with<br>Chemotherapy Drugs | N/A |
| 510(k) Reference | K162982 | K160562 | K151750 | N/A |
| Product Owner | Medline Industries,<br>Inc. | Hartalega | Kossan | Different |
| Product Code | LZA, LZC | LZA., LZC | LZA, LZC | Same |
| Intended Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand to<br>prevent contamination<br>between patient and<br>examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs<br>as per ASTM D6978-<br>05 (Reapproved 2013)<br>Standard Practice for<br>Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | A non-sterile<br>disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. These<br>gloves were tested<br>for use with<br>Chemotherapy Drugs<br>in accordance with<br>ASTM D6978-05,<br>Standard Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | A patient<br>examination glove is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs<br>as per ASTM<br>D6978-05<br>(Reapproved 2013)<br>Standard Practice for<br>Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile<br>Colloidal oatmeal | Nitrile<br>Colloidal oatmeal | Nitrile | Same as K160562 |
| Color | White | White | White | Same |
| Sizes | x-small, small, medium, large, x-large | x-small, small, medium, large, x-large | x- small, small, medium, large, x-large, xx-large | Same |
| Dimensions – Length | Complies with ASTM D6319-10<br>230mm min. | Complies with ASTM D6319-10<br>240mm min. | Complies with ASTM D6319-10<br>230mm min. | Same as K151750 and similar to K160562 which is 10mm longer than the subject device. |
| Dimensions – Width | Complies with ASTM D6319-10<br>X-small – 70±10mm<br>Small – 80±10mm<br>Medium – 95±10mm<br>Large – 110±10mm<br>X-large – 120±10mm | Complies with ASTM D6319-10<br>Medium – 95mm | Complies with ASTM D6319-10<br>X-small – 70-80mm<br>Small – 80-90mm<br>Medium – 90-100mm<br>Large – 101-11mm<br>X-large – 111-121mm<br>XX-large – 121-131mm | Same as K160562 and similar to K151750. |
| Dimensions – Thickness | Complies with ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Complies with ASTM D6319-10<br>Palm – 0.07mm min.<br>Finger – 0.07mm min. | Complies with ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Same as K151750 and similar to K160562 |
| Physical Properties | Complies with ASTM D6319-10 minimum: | Complies with ASTM D6319-10 minimum: | Complies with ASTM D6319-10 minimum: | Same |
| | Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br><br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br><br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br><br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | |
| Freedom from Holes | Complies with ASTM D6319-10 and ASTM D5151-06<br>(reapproved 2011) G-1, AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011) AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011) G-1, AQL 1.5 | Same |
| Powder or Powder-Free | Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with ASTM D6319-10 <2mg per glove | Complies with ASTM D6319-10 <2mg per glove | Complies with ASTM D6319-10 <2mg per glove | Same |
| Contact<br>Durations | Limited ≥24 hours | Limited ≥24 hours | Limited ≥24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | Same |
| Sterile vs. Non-<br>Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Chemotherapy<br>Drugs Tested with<br>Minimum<br>Breakthrough<br>Detection Time as<br>tested per ASTM<br>D6978 | Blenoxane 15 mg/ml<br>>240 min. | | | Different |
| | Bortezomib 1 mg/ml<br>>240 min. | | | Different |
| | Busulfan 6 mg/ml<br>>240 min. | | | Different |
| | Carmustine (BCNU)<br>3.3 mg/ml<br>11.9 min. | Carmustine<br>3.3 mg/ml<br>10.1 min. | Carmustine (BCNU)<br>3.3 mg/ml<br>10.1 min. | Same |
| | Cetuximab (Erbitux)<br>2 mg/ml<br>>240 min. | | | Different |
| | Cisplatin 1.0 mg.ml<br>>240 min. | Cisplatin 1.0 mg.ml<br>>240 min. | Cisplatin 1.0 mg.ml<br>>240 min. | Same |
| | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml<br>>240 min. | Cyclophosphamide<br>(Cytoxan) 20 mg/ml<br>>240 min. | Cyclophosphamide<br>(Cytoxan) 20 mg/ml<br>>240 min. | Same |
| | Cytarabine 100 mg/ml<br>>240 min. | | Cytarabine 100<br>mg/ml<br>>240 min. | Different |
| | Dacarbazine<br>(DTIC)10.0 mg/ml<br>>240 min. | Dacarbazine<br>(DTIC)10.0 mg/ml<br>>240 min. | Dacarbazine<br>(DTIC)10.0 mg/ml<br>>240 min. | Same |
| | Daunorubicin 5<br>mg/ml<br>>240 min. | | | Different |
| | Docetaxel 10.0 mg/ml<br>>240 min. | | | Different |
| | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml<br>>240 min. | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml<br>>240 min. | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml<br>>240 min. | Same |
| | Ellence 2 mg/ml<br>>240 min. | | | Different |
| | Etoposide (Toposar)<br>20.0 mg/ml<br>>240 min. | Etoposide (Toposar)<br>20.0 mg/ml<br>>240 min. | Etoposide (Toposar)<br>20.0 mg/ml<br>>240 min. | Same |
| | Fludarabine 25 mg/ml<br>>240 min. | | | Different |
| Fluorouracil 50.0<br>mg/ml<br>>240 min. | Fluorouracil 50.0<br>mg/ml<br>>240 min. | Fluorouracil 50.0<br>mg/ml<br>>240 min. | Same | |
| Gemcitabine<br>(Gemzar) 38 mg/ml<br>>240 min. | | | Different | |
| Idarubicin 1 mg/ml<br>>240 min. | | | Different | |
| Ifosfamide 50.0<br>mg/ml<br>>240 min. | | Ifosfamide (IFEX)<br>50 mg/ml<br>>240 min. | Different | |
| Irinotecan 20.0 mg/ml<br>>240 min. | | | Different | |
| Mechlorethamine<br>HCI 1.0 mg/ml<br>>240 min. | | | Different | |
| Melphalan 5 mg/ml<br>>240 min. | | | Different | |
| Methotrexate 25<br>mg/ml<br>>240 min. | Methotrexate 25<br>mg/ml<br>>240 min | Methotrexate 25<br>mg/ml<br>>240 min. | Same | |
| Methotrexate 50<br>mg/ml<br>>240 min. |…