Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

K211810 · Pt. Shamrock Manufacturing Corpora · LZA · May 23, 2022 · General Hospital

Device Facts

• Record ID: K211810
• Device Name: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
• Applicant: Pt. Shamrock Manufacturing Corpora
• Product Code: LZA · General Hospital
• Decision Date: May 23, 2022
• 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 purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.

Device Story

Disposable, non-sterile, powder-free blue nitrile examination gloves; worn by healthcare examiners to provide barrier protection against contamination. Tested for permeation resistance against specific chemotherapy drugs and fentanyl per ASTM D6978-05(2019). Used in clinical settings; provides barrier protection; helps prevent cross-contamination between patient and examiner. Labeling includes caution for drugs with lower breakthrough times (Carmustine, Thiotepa).

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-10, ISO 10993-5, ISO 10993-11) and permeation resistance to chemotherapy drugs and fentanyl per ASTM D6978-05(2019).

Technological Characteristics

Material: Powder-free nitrile. Form: Ambidextrous, blue, beaded cuff. Standards: ASTM D6319-19 (dimensions, physical properties, residue), ASTM D6978-05(2019) (chemotherapy permeation). Sterilization: Non-sterile.

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 chemotherapy drugs and fentanyl.

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

• YTY Industry (Manjung): Non-sterile, Powder-free Nitrile Examination Gloves (Cobalt Blue) tested for use with Chemotherapy Drugs (K111248)

Submission Summary (Full Text)

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May 23, 2022

PT. Shamrock Manufacturing Corpora Jeni Chuason Regulatory Affairs Manager JL. Raya Medan - Namorambe Ps IV Kab. Deli Serdang, North Sumatera 20356 Indonesia

Re: K211810

Trade/Device Name: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for used with Chemotherapy Drugs and Fentanyl) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: April 12, 2022 Received: April 13, 2022

Dear Jeni Chuason:

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.

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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 ([e-mail]) or phone [phone] 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

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#### Indications for Use

510(k) Number (if known) K211810

#### Device Name

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs and Fentanyl)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.

| Chemotherapy Drug and Permeation | |
|-------------------------------------------------------------|----------------------------------------|
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
| Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) | > 240 min. |
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 46.6 min. |
| Chloroquine 50mg/ml (50,000ppm) | > 240 min |
| Cisplatin, 1.0 mg/ml (1,000ppm) | > 240 min |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0mg/ml (10,000ppm) | > 240 min |
| Docetaxel, 10mg/ml (10,000ppm) | > 240 min |
| Doxorubicin HCI, 2.0mg/ml (2,000ppm) | > 240 min |
| Etoposide, 20.0mg/ml (20,000ppm) | > 240 min |
| Fluorouracil, 50.0mg/ml (50,000ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| Thiotepa, 10.0mg/ml (10,000ppm) | 64.8 min |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Fentanyl Citrate Injection 100mcg/2ml (50mcg/1ml) | > 240 min |

Please note that the following drugs that have low permeation time are: Carmustine (BCNU), 3.3 mg/ml 46.6 min Thiotepa, 10.0mg/ml 64.8 min CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Jl. Raya Medan - Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara - Indonesia Tel. [phone] Fax. [phone] Email: [e-mail]

### 510(k) SUMMARY

#### Submitter:

Contact Person:

#### PT. SHAMROCK MANUFACTURING CORPORA

Address:

Email:

Jl. Raya Medan, Namorambe PS. IV Kab. Deli Serdang Sumatera Utara, Indonesia Tel. [phone] Fax. [phone] Imelda/Jeni Chuason [e-mail]

Summary Preparation Date: April 12, 2022

Type of 510(k) Submission: Traditional

#### Proprietary/Trade Name:

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

#### Common Name:

Powder Free Nitrile Examination Gloves, Specialty

#### Regulation Name:

Patient Examination Glove, Specialty (21 CFR 880.6250)

#### Classification Name:

Patient Exam Glove, Medical Gloves with Chemotherapy / Fentanyl Labeling Claims

LZA, LZC, OPJ, QDO Product Code:

Regulatory Class: Class I

#### Predicate Device:

YTY Industry (Manjung): Non-sterile, Powder-free Nitrile Examination Gloves (Cobalt Blue) tested for use with Chemotherapy Drugs (K111248)

#### Device Description:

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier

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Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).

#### Indications of Use:

A patient examination qlove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These qloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.

| Chemo Drugs tested: | Breakthrough Time<br>(Minutes) |
|------------------------------------------------------|--------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 46.6 |
| Chloroquine 50 mg/ml (50,000 ppm) | > 240 |
| Cisplatin 1 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide20 mg/ml (20,000 ppm) | > 240 |
| Doxorubicin HCL 2 mg/ml (2,000 ppm) | > 240 |
| Etoposide 20 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil 50 mg/ml (50,000 ppm) | > 240 |
| Paclitaxel 60 mg/ml (6,000 ppm) | > 240 |
| Thiotepa 10 mg/ml (10,000 ppm) | 64.8 |
| Carboplatin 10 mg/ml (10,000 ppm) | > 240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | > 240 |
| Docetaxel 10 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide 50 mg/ml (50,000 ppm) | > 240 |
| Methotrexate 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | > 240 |
| Vincristine Sulfate 1 mg/ml (1,000 ppm) | > 240 |
| Fentanyl Citrate Injection 100 mcg/2 ml (50 mcg/1mL) | > 240 |

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Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.

### Comparison of Technological Characteristics

Comparison of Proposed Device to Predicate Device

| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Shamrock Powder Free<br>Blue Nitrile Examination<br>Gloves (Tested for use<br>with Chemotherapy<br>Drugs and Fentanyl) | Non-Sterile, Powder-<br>Free Nitrile<br>Examination Gloves<br>(Cobalt) Tested for use<br>within chemotherapy<br>drugs | N/A |
| 510(K)<br>Reference | K211810 | K11248 | N/A |
| Product Owner | PT. Shamrock<br>Manufacturing Corpora | YTY Industry (Manjung)<br>SDN, BHD | N/A |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC | Similar |
| Indications for<br>Use | A patient Examination<br>Glove is a disposable<br>device intended for<br>medical purpose that is<br>worn on examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were<br>tested for use with<br>Chemotherapy Drugs as<br>per ASTM D6978-05<br>(2019) Standard<br>Practice for Assessment<br>of Medical Gloves of<br>Permeation by<br>Chemotherapy Drugs | A patient examination<br>glove is a disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or fingers to<br>prevent contamination<br>between patient and<br>examiner. These gloves<br>were tested for use<br>with chemotherapy<br>drugs | Same |
| Regulation<br>number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
| Materials | Powder- Free Nitrile | Powder- Free Nitrile | Same |
| Color | Blue | Blue | Same |
| Sizes | x-small, small, medium,<br>large, x-large, xx-large | Medium, Large, Extra-<br>large | Similar |
| Dimensions<br>Length | Complies with:<br>ASTM D6319-19<br>220mm min | Complies with: ASTM<br>D6319-10<br>220mm min | Same |
| Dimensions<br>Width | Complies with:<br>ASTM D6319-19<br>70mm min | Complies with: ASTM<br>D6319-10<br>70mm min | Same |
| Dimensions<br>Thickness | Complies with:<br>ASTM D6319-19<br>Palm - 0.05mm min<br>Finger – 0.05mm min | Complies with: ASTM<br>D6319-10<br>Palm - 0.05mm min<br>Finger – 0.05mm min | Same |
| Physical<br>Properties | Complies with<br>ASTM D6319-19<br>Tensile Strength:<br>Before Aging ≥ 14 Mpa<br>(min)<br>After Aging ≥ 14 Mpa<br>(min) | Complies with:<br>ASTM D6319-10<br>Tensile Strength:<br>Before Aging ≥ 14 Mpa<br>(min)<br>After Aging ≥ 14 Mpa<br>(min) | Same |
| Physical<br>Properties | Elongation:<br>Before Aging 500%<br>After Aging 400% | Elongation:<br>Before Aging 500%<br>After Aging 400% | Same |
| Freedom from<br>Holes | Complies with:<br>ASTM D6319-19<br>ASTM D5151<br>AQL 2.5 | Complies with: ASTM<br>D6319-19<br>AQL 2.5 | Similar |
| Powder or<br>Powder-free | Powder-free | Powder-free | Same |
| Residue Powder | Complies with:<br>ASTM D6319-19 < 2<br>mg per glove | Complies with: ASTM<br>D6319-19 < 2 mg per<br>glove | same |
| Contact<br>Durations | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| Biocompatibility | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>ISO 10993-5:<br>Exhibit severe<br>cytotoxicity reactivity<br>ISO 10993-11:<br>Not Toxic | ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>ISO 10993-5:<br>Not available<br>ISO 10993-11:<br>Not available | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| Tested<br>Chemotherapy<br>Drugs | Carboplatin 10 mg/ml<br>(10,000 ppm) > 240<br>min | Carboplatin 10 mg/ml<br>(6,000 ppm) > 240 min | Same |
| | Dacarbazine (DTIC)<br>10.0 mg/ml (10,000<br>ppm) > 240 min | Dacarbazine (DTIC)<br>10.0 mg/ml (10,000<br>ppm) > 240 min | Same |
| | Docetaxel 10.0 mg/ml<br>(10,000 ppm) > 240<br>min | | Different |
| | Ifosfamide 50.0 mg/ml<br>(50,000 ppm) > 240<br>min | Ifosfamide 50.0 mg/ml<br>(50,000 ppm) > 240<br>min | Same |
| | Methotrexate 25.0<br>mg/ml (25,000 ppm)<br>> 240 min | Methotrexate 25.0<br>mg/ml (25,000 ppm)<br>> 240 min | Same |
| | Mitomycin C 0.5 mg/ml<br>(500 ppm) > 240 min | Mitomycin C 0.5 mg/ml<br>(500 ppm) > 240 min | Same |
| | Vincristine Sulfate 1<br>mg/ml (1,000 ppm)<br>> 240 min | | Different |
| | Carmustine 3.3 mg/ml<br>(3,300 ppm) 46.6 min | Carmustine 3.3 mg/ml<br>(3,300 ppm) 1.82 min | Same |
| | | | |
| | Chloroquine 50 mg/ml<br>(50,000 ppm) > 240 min | | Different |
| | Cisplatin 1 mg/ml<br>(1,000 ppm) > 240 min | Cisplatin 1 mg/ml<br>(1,000 ppm) > 240 min | Same |
| | Cyclophosphamide 20.0<br>mg/ml (20,000 ppm)<br>> 240 min | Cyclophosphamide 20.0<br>mg/ml (20,000 ppm)<br>> 240 min | Same |
| | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml (2,000 ppm)<br>> 240 min | Doxorubicin<br>Hydrochloride 2.0<br>mg/ml (2,000 ppm)<br>> 240 min | Same |
| | Etoposide 20.0 mg/ml<br>(20,000 ppm)<br>> 240 min | Etoposide 20.0 mg/ml<br>(20,000 ppm)<br>> 240 min | Same |
| | Fluorouracil 50.0 mg/ml<br>(50,000 ppm)<br>> 240 min | Fluorouracil 50.0<br>mg/ml (50,000 ppm)<br>> 240 min | Same |
| | Paclitaxel 6.0 mg/ml<br>(6,000 ppm) > 240 min | Paclitaxel 6.0 mg/ml<br>(6,000 ppm) > 240 min | Same |
| | Thiotepa 10.0 mg/ml<br>(10,000 ppm) > 240<br>min | Thiotepa 10.0 mg/ml<br>(10,000 ppm) > 240<br>min | Same |
| Fentanyl<br>Testing | Fentanyl Citrate, 100<br>mcg/2ml > 240 min | | Different |

{7}------------------------------------------------

Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

{8}------------------------------------------------

Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

{9}------------------------------------------------

Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

#### Summary of Non-Clinical Testing

#### Biocompatibility Testing

Below summary is the biocompatibility results for Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl).

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Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone]

Email: [e-mail]

| Name of test /<br>citation | Purpose | Acceptance<br>Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------|-------------------------------------------------------|
| ISO 10993-10:<br>Biological Evaluation of<br>Medical Devices, Part<br>10-Test for Irritation<br>and Skin Sensitization | Irritation<br>Testing | Pass/Fail | Pass<br>Not a skin irritant |
| ISO 10993-10:<br>Biological Evaluation of<br>Medical Devices, Part<br>10-Test for Irritation<br>and Skin Sensitization | Sensitization<br>Testing | Pass/Fail | Pass<br>Not a skin<br>sensitizer |
| Name of test /<br>citation | Purpose | Acceptance<br>Criteria | Results |
| ISO 10993-5:<br>Biological Evaluation of<br>Medical Devices, Part<br>5: Test for in vitro<br>cytotoxicity | Cytotoxicity<br>Testing | Pass/Fail | Fail<br>Exhibits severe<br>cytotoxicity<br>reactivity |
| ISO 10993-11:<br>Biological Evaluation of<br>Medical Devices, Part<br>11: Test for Systemic<br>Toxicity | Systemic<br>Toxicity<br>Testing | Pass/Fail | Pass<br>Not toxic |

#### Permeation Testing

These gloves were tested to support the labeling claim: Tested for use with Chemotherapy Drugs and Fentanyl. The gloves were tested according to ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs and Fentanyl. Below table is the summary of the minimum breakthrough times.

Please note that the following drugs, Carmustine and Thiotepa have low permeation time of 46.6 minutes and 64.8 minutes (less than 240 minutes). Labeling will include caution statement in the presence of these chemotherapy druqs.

{11}------------------------------------------------

Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. [phone] Fax. [phone] Email: [e-mail]

| Test Chemotherapy Drugs | Average<br>Breakthrough<br>Time |
|-----------------------------------------------------|---------------------------------|
| Carboplatin (Paraplatin), 10 mg/ml (10,000 ppm) | > 240 min |
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 46.6 min |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | > 240 min |
| Cloroquine 50 mg/ml (50,000 ppm) | >2400 min |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | > 240 min |
| Docetaxel, 10 mg/ml (10,000 ppm) | > 240 min |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) | > 240 min |
| Etoposide, 20.0 mg/ml (20,000 ppm) | > 240 min |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25 mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | 64.8 min |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Fentanyl Citrate Injection 100 mcg/2ml (50 mcg/1ml) | > 240 min |

### Clinical Test Conclusion

Not applicable

### Conclusion

The conclusions drawn from the non-clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.