Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

K221626 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LZA · Dec 7, 2022 · General Hospital

Device Facts

• Record ID: K221626
• Device Name: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
• Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 7, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

Device Story

Disposable blue nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer; powder-free; non-sterile. Tested for permeation resistance against various chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (2019). Used in clinical settings; provides barrier protection. Output is physical barrier; affects clinical decision-making by ensuring safety during handling of hazardous drugs. Benefits patient and clinician by reducing exposure to contaminants and hazardous substances.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing (ASTM D6319-2019), watertightness (ASTM D5151-2019), residual powder (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility testing performed per ISO 10993 series.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form: Powder-free, blue, non-sterile. Sizes: Small, Medium, Large, Extra Large. Standards: ASTM D6319-2019 (physical properties), ASTM D6978-05 (2019) (chemotherapy permeation), ASTM D5151-2019 (watertightness), ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination. Tested for use with specific chemotherapy drugs and Fentanyl Citrate.

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

• Halyard Lavender Nitrile, Powder-free Exam Gloves Tested for use with Chemotherapy Drugs and Fentanyl Citrate (K202622)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

December 7, 2022

JR Engineering & Medical Technologies (M) SDN. BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504

Re: K221626

Trade/Device Name: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate 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: November 10, 2022 Received: November 14, 2022

Dear Manoj Zacharias:

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,

# Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. 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) K221626

#### Device Name

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

#### Indications for Use (Describe)

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|-----------------------------------------------|-------------------------------------|
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
| Vinblastine (1 mg/ml) | >240 Minutes |
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |

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| Cisplatin (1 mg/ml) | >240 Minutes |
|---------------------------------------|--------------|
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |

The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes

Warning: Do not use with Carmustine or Thiotepa.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY K221626 As required by: 21CFR§807.92(c)

#### A. APPLICANTINFORMATION

| 510(K) Owner's Name | JR Engineering & Medical Technologies (M) Sdn. Bhd. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1,<br>Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor<br>Darul Ehsan, Malaysia. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | 10th November 2022 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Jr Medic Blue Nitrile Examination Gloves Powder Free<br>tested for use with Chemotherapy drugs and Fentanyl<br>Citrate |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty &<br>Fentanyl and other opioid protection glove |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, QDO, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

#### C. PREDICATE DEVICE

| Predicate Device | Halyard Lavender Nitrile, Powder-free Exam Gloves<br>Tested for use with Chemotherapy Drugs and Fentanyl<br>Citrate |
|------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K202622 |
| Regulatory Class | 1 |
| Product code | LZC, QDO |

## D. DESCRIPTION OF THEDEVICE:

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate.

The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is

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available in Small, Medium, Large and Extra Large sizes.

The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

#### E. INTENDED USE OF THE DEVICE/INDICATIONS FOR USE:

Ir Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

| Tested Chemotherapy Drug Name & | Minimum Breakthrough Detection |
|---------------------------------|--------------------------------|
| Concentration | Time (Minutes) |
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |

The tested chemotherapy drugs and their breakthrough detection times are as follows:

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| Vinblastine (1 mg/ml) | >240 Minutes |
|---------------------------------------|--------------|
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |

The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes

Warning: Do not use with Carmustine (BCNU) & Thiotepa

#### F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
|---------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | PREDICATE | PROPOSED DEVICE | |
| 510(K) Number | - | K202622 | K221626 | |
| Name of device | | Halyard Lavender<br>Nitrile, Powder-<br>free Exam Gloves<br>Tested for use<br>with<br>Chemotherapy<br>Drugs and<br>Fentanyl Citrate | Jr Medic<br>Blue Nitrile<br>Examination Gloves<br>Powder Free tested<br>for use with<br>Chemotherapy drugs<br>and Fentanyl Citrate | Similar |
| Product Code | - | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Similar |
| Intended use /<br>Indications for Use | | The Halyard<br>Lavender Nitrile,<br>Powder-free Exam<br>Gloves<br>Tested for use<br>with<br>Chemotherapy<br>Drugs and | Jr Medic Blue Nitrile<br>Examination Gloves<br>Powder Free tested<br>for use with<br>Chemotherapy drugs<br>and Fentanyl Citrate<br>is a disposable device<br>intended for medical | Similar |

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| | | Fentanyl Citrate<br>are disposable | purpose that is worn<br>on the examiner's | |
|--|--|------------------------------------|-------------------------------------------|--|
|--|--|------------------------------------|-------------------------------------------|--|

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
|-------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | PREDICATE<br>K202622 | PROPOSED<br>DEVICE | |
| | | device intended<br>for medical<br>purpose that is<br>worn on the<br>examiner's hand<br>to prevent<br>contamination<br>between patient<br>and examiner.<br>The gloves were<br>tested for use<br>with the<br>chemotherapy<br>drugs and<br>Fentanyl Citrate<br>as per ASTM D<br>6978-05 | hand to prevent<br>contamination<br>between patient<br>and examiner.<br>Additionally, the<br>gloves were tested<br>for use with<br>chemotherapy<br>drugs and<br>Fentanyl Citrate in<br>accordance with<br>ASTM D6978-05<br>(2019) Standard<br>Practice for<br>Assessment of<br>Medical Glove to<br>Permeation by<br>Chemotherapy<br>Drugs. | |
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Lavender | Blue | Different |
| Size | ASTM D6319-<br>2019 | Extra Small,<br>Small, Medium,<br>Large, Extra Large | Small, Medium,<br>Large, Extra Large | Similar |
| Single Use | Medical Glove<br>Guidance<br>Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-<br>2019 | Length:<br>295-325 mm<br>Width<br>XS- 60-80mm<br>S- 70-90mm<br>M- 85-105mm<br>L- 100-120mm<br>XL- 110-130mm | Length > 230 mm<br>Width Min 95+/-<br>10 mm(for<br>medium size) | Similar |
| CHARACTE<br>RSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
| | | PREDICATE DEVICE<br>K202622 | PROPOSED DEVICE<br>K221626 | |
| Physical<br>Properties | ASTM D6319-2019 | <b>Before Ageing</b><br>Tensile Strength<br>$\ge$ 14 Mpa<br>Ultimate Elongation<br>$\ge$ 500%<br><b>After Ageing</b><br>Tensile Strength<br>$\ge$ 14 Mpa<br>Ultimate Elongation<br>$\ge$ 400% | <b>Before Ageing</b><br>Tensile Strength<br>> 14 Mpa<br>Ultimate Elongation<br>>500%<br><b>After Ageing</b><br>Tensile Strength<br>>14 Mpa<br>Ultimate Elongation<br>> 400% | Similar |
| Thickness | ASTM D6319-2019 | Palm<br>0.10-0.16 mm<br>Finger<br>0.10-0.19 mm | Palm >0.05 mm<br>Finger > 0.05 mm | Similar |
| Powder Free<br>Residue | ASTM D6319-2019 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar |
| Watertight<br>(1000 ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and<br>Labeling | FDA Label<br>requirements | Meets FDA's<br>requirements | Meets FDA's<br>requirements | Same |
| Bio-<br>compatibility | Primary Skin<br>Irritation-ISO 10993-<br>10:2010<br>(E) | Under the condition of<br>study the device<br>extracts were not found<br>to cause a systemic<br>response in the animal<br>model. | Under the condition<br>of study not an<br>irritant | Similar |
| | Dermal Sensitization-<br>ISO 10993-10:2010<br>(E) | No Data Available | Under the conditions<br>of the study not a<br>sensitizer | ---- |
| | In vitro<br>cytotoxicity<br>ISO10993-5 :2009(E) | No Data Available | Under the<br>conditions of the<br>study, cytotoxic | ---- |
| | Material<br>Mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) /<br>USP 41<151> | No Data Available | Under the<br>conditions of<br>the study no<br>material-<br>mediated<br>pyrogenic | ---- |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the conditions of<br>the study, the test<br>article was considered<br>non toxic | Under the condition<br>of study does not<br>induce any systemic<br>toxic concern | Similar |

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| Chemotherapy Drugs tested with Minimum Breakthrough Detection Time as tested per ASTM | | | | |
|---------------------------------------------------------------------------------------|--------------|--------------|-----------|--|
| D6978-05 (2019) | | | | |
| | | | | |
| Bendamustine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Bleomycin (15 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Carfilzomib (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cetuximab (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cladribine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Decitabine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fulvestrant (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mechlorethamine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Oxaliplatin (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Paraplatin (10 mg/ml) | Not Tested | >240 Minutes | Different | |
| Pemetrexed (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Topotecan (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Triclosan (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinblastine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinorelbine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Capecitabine (26 mg/ml) | >240 Minutes | Not Tested | Different | |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dactinomycin (0.5 mg/ml) | >240 Minutes | Not Tested | Different | |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |

{10}------------------------------------------------

| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
|---------------------------------------|--------------|--------------|-----------|
| Leuprolide Acetate Salt ( 5<br>mg/ml) | >240 Minutes | Not Tested | Different |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Temsirolimus (25 mg/ml) | >240 Minutes | Not Tested | Different |
| Vincristine (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 Minutes | Not Tested | Different |
| Carmustine (3.3 mg/ml) | 0.3 Minutes | 35.0 Minutes | Different |
| Thiotepa (10 mg/ml) | 30.9 Minutes | 64.9 Minutes | Different |

Hazardous Drugs (opioid) tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-05 (2019)

| Fentanyl Citrate (100 mg/ml) | >240 Minutes | >240 Minutes | Same |
|------------------------------|--------------|--------------|------|
|------------------------------|--------------|--------------|------|

There are no significant differences between the proposed device and the predicate device and are identical in terms of intended use, materials, design, manufacturing methods & resistance of medical gloves to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978- 05(2019).

#### G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|--------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------|
| ASTM D6319-2019<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | To determine the length<br>of the gloves | Min 220 mm for Size<br>Small & Min 230 mm<br>for all other sizes | Small:- 404 mm<br>Medium:- 405 mm<br>Large:- 405 mm<br>X-Large:- 406 mm |

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

| Test Method | Purpose | Acceptance Criteria | Result | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>width of the gloves | Small:- $80+/-10$ mm<br>Medium:- $95+/-10$ mm<br>Large:- $110+/-10$ mm<br>X-Large:- $120+/10$ mm | Small:- 84 mm<br>Medium:- 94 mm<br>Large:- 105 mm<br>X-Large:- 115 mm | | | | | | | | | | | | | | | |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>for all sizes | Size Palm Finger Small 0.19mm 0.21mm Medium 0.19mm 0.21mm Large 0.19mm 0.21mm X-Large 0.19mm 0.21mm | | | | | | | | | | | | | | | |
| | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size Before<br>ageing After<br>ageing Small 22.77Mpa 20.50Mpa Medium 24.46Mpa 21.81Mpa Large 24.51Mpa 21.95Mpa X-Large 24.59Mpa 22.05Mpa | | | | | | | | | | | | | | | |
| | | After Ageing Tensile<br>Strength 14Mpa Min<br>for all sizes | | | | | | | | | | | | | | | | |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes | Size Before<br>ageing After<br>ageing Small 885% 868% Medium 888% 870% Large 891% 872% X-Large 892% 875% | | | | | | | | | | | | | | | |
| | | After Ageing<br>Ultimate Elongation<br>400% Min for all<br>sizes | | | | | | | | | | | | | | | | |

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved<br>2017) Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | 2 Mg/Glove Max | Size<br>Small 0.16 mg/glove<br>Medium 0.16 mg/glove<br>Large 0.16 mg/glove<br>X-Large 0.16mg/glove |

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## PERMEATION TEST RESULT AS PER ASTM D6978

| Test Chemotherapy Drugs | Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) | Avg. Steady<br>State<br>Perm. Rate<br>(µg/cm²/Minute) | Other Observations |
|------------------------------------|--------------------------------------------------------|-------------------------------------------------------|----------------------------------|
| Bendamustine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Bleomycin (15 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Busulfan (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carfilzomib (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cetuximab (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cladribine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cytarabine (100 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Decitabine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Docetaxel (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fludarabine (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fulvestrant (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Gemcitabine (38 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Irinotecan (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mechlorethamine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Melphalan (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Oxaliplatin (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paraplatin (10 mg/ml) | Not Tested | NA | Slight swelling & no degradation |
| Pemetrexed (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Rituximab (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Topotecan (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Triclosan (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Trisenox (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Velcade (Bortezomib)<br>(1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vidaza (Azacytidine)<br>(25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinblastine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinorelbine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carboplatin (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cisplatin (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Dacarbazine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Etoposide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Ifosfamide (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Test Chemotherapy Drugs | Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) | Avg. Steady<br>State<br>Perm. Rate<br>(µg/cm²/Minute) | Other Observations |
| Methotrexate (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitoxantrone (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paclitaxel (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vincristine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carmustine (3.3 mg/ml) | 35.0 Minutes | NA | Slight swelling & no degradation |
| Thiotepa (10 mg/ml) | 64.9 Minutes | NA | Slight swelling & no degradation |

{13}------------------------------------------------

# H. NON- CLINICAL TESTING BIO-COMPATABILITY DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done for<br>irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Non irritant | Under the condition of<br>study not an irritant |
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>Guinea Pig. | Non sensitizer | Under the conditions of<br>the study not a<br>sensitizer |
| ISO 10993-5:2009 biological<br>evaluation of medical devices -<br>part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner and outer<br>surface) Extracts in L-929<br>mouse fibroblasts cells using<br>elution method. | Non cytotoxic | Under the conditions of<br>the study cytotoxic. |
| ISO 10993-11:2017 biological<br>evaluation of medical devices -<br>part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts (both<br>inside and outer surfaces) in<br>Swiss Albino mice. | Not pose systemic<br>toxicity concern | Under the conditions<br>of study the device<br>extracts do not pose<br>acute systemic<br>toxicity concern |
| Material<br>Mediated<br>Pyrogenicity ISO 10993-<br>11:2017(E) / USP 41<151> | To determine the pyrogenic<br>potential of the test item<br>extract following intravenous<br>injection in New Zealand<br>white Rabbits. | Not pose material<br>mediated<br>pyrogenicity<br>response | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. |

{14}------------------------------------------------

## I. Clinical Testing Summary

No clinical information is included in this submission

# J. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.