Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

K192954 · Comfort Rubber Gloves Industries Sdn. Bhd. · LZA · Jun 19, 2020 · General Hospital

Device Facts

• Record ID: K192954
• Device Name: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
• Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable nitrile examination glove; worn by clinicians to prevent cross-contamination between examiner and patient; provides barrier protection against chemotherapy drugs and Fentanyl Citrate. Device input is physical contact with patient or hazardous substances; device acts as a physical barrier. Output is protection of the wearer and patient. Used in clinical settings; operated by healthcare professionals. Benefits include reduced risk of infection transmission and protection from chemical exposure during handling of chemotherapy agents and Fentanyl Citrate.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via ASTM D412 (tensile strength/elongation), ASTM D5151 (water leak), ASTM D6124 (powder residue), ASTM D6978 (chemotherapy permeation), and ISO 10993 series (biocompatibility, irritation, sensitization, cytotoxicity, and acute systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, blue-colored examination glove. Dimensions: Min 240mm length, min 0.05mm thickness. Standards: ASTM D6319-10(2015), ASTM D6978-05, ASTM D412-2016, ASTM D5151-2006, ASTM D6124-2006, ISO 10993-5, ISO 10993-10, ISO 10993-11. Non-sterile.

Indications for Use

Indicated for use as a disposable patient medical examination glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient, and to protect the wearer against exposure to 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

• Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K183287)

Submission Summary (Full Text)

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August 24, 2022

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe QA Manager Lot 821, Jalan Matang Matang, 34750 Malaysia

Re: K192954

Trade/Device Name: Blue Colored, Power Free Nitrile Examination Gloves 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, QDO

Dear Ng Kok Howe:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 19, 2020. Specifically, FDA is updating this SE Letter for a typographical error contained in the Indications for Use and 510(k) Summary, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, Office of Surgical and Infection Control Devices, at: [phone] or [e-mail].

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

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June 19, 2020

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe QA Manager Lot 821, Jalan Matang Matang, 34750 My

Re: K192954

Trade/Device Name: Blue Colored, Power Free Nitrile Examination Gloves 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, QDO, Dated: November 29, 2019 Received: May 11, 2020

Dear Ng Kok Howe:

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.

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

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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-reporting-

combination-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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Elizabeth F. Claverie -S

CAPT Elizabeth Claverie, M.S. 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) K192954

### Device Name

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

### Indications for Use (Describe)

The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| | Tested chemotherapy drugs are as follows: | Average Breakthrough Detection Time (minutes) |
|--|------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Cisplatin 1.0 mg/ml | ≥ 240 |
| | Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| | Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| | Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| | Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| | Fluorouracil 50.0 mg/ml | ≥ 240 |
| | Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
| | Carmustine (BCNU) -3.3 mg/ml | 18.2 |
| | Thiotepa (THT) -10.0 mg/ml | 57.3 |
| | Tested Fentanyl Citrate is as follows:<br>Fentanyl Citrate Injection 100.0 mcg/2ml | Average Breakthrough Detection Time (minutes) ≥ 240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 18.2 minutes and Thiotepa: 57.3

minutes. Warning: Do not use with Carmustine.

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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## 510(k) SUMMARY - K192954

#### 1.0 Submitter :

| Name | : Comfort Rubber Gloves Industries Sdn. Bhd. |
|----------------|-------------------------------------------------------------------------|
| Address | : Lot 821, Jalan Matang,<br>34750 Matang, Perak, Malaysia.<br>Malaysia. |
| Phone No. | : 605-847 2777 |
| Fax No. | : 605-847 9108 |
| Contact Person | : Ng Kok Howe (Mr.) |

Date of Preparation : June 10, 2020

#### 2.0 Name of the Device

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

| Common Name : | Patient Examination Gloves |
|-----------------------|--------------------------------------------------------------------------------------------------------|
| Classification Name : | Patient Examination Gloves (21 CFR 880.6250 )<br>Patient Examination Gloves Specialty (21 CFR 880.6250 |
| 510(K) Number : | K192954 |
| Device Class : | I |
| Product code : | LZA, LZC, QDO |

#### 3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

- Device Name : Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Company : Kossan International Sdn. Bhd.

510(K) No. : K183287

#### 4.0 Description of the Device:

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

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#### 5.0 Indication for Use of the Device

The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

| | Average Breakthrough Detection Time (minutes) |
|-------------------------------------|-----------------------------------------------|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
| Carmustine (BCNU) -3.3 mg/ml | 18.2 |
| Thiotepa (THT) -10.0 mg/ml | 57.3 |

Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time (minutes) Fentanyl Citrate Injection 100.0 mcg/2ml ≥ 240

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 18.2 minutes and Thiotepa: 57.3 minutes. Warning: Do not use with Carmustine.

#### 6.0 Summary of the Technological Characteristics of the Device:

The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.

Chemotherapy claim is similar to Predicate, which has a gloves thickness comply with the ASTM Standards.

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## Table 1

## Technological Characteristic Comparison Table

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|------------------------------|--------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|------------|
| Manufacturer(s) | | Kossan International<br>Sdn. Bhd. | Comfort Rubber Gloves<br>Industries Sdn. Bhd | Different |
| 510(k) number | | K183287 | K192954 | |
| Dimension | ASTM D6319 -<br>10(2015) | Length-Min 240mm<br>Thickness palm and<br>finger- Min 0.05mm | Length-Min 240mm<br>Thickness palm and<br>finger- Min 0.05mm | Similar |
| Physical Properties | ASTM D6319 -<br>10(2015) | Meets | Meets | Similar |
| Thickness – Finger<br>- Palm | ASTM D6319 -<br>10(2015) | Meets | Meets | Similar |
| Powder Content | ASTM D6124 -<br>06(2011)<br>(≤ 2 mg/glove) | Meets | Meets | Similar |

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate | | | | |
| Chemotherapy<br>Drug<br>Permeation Test | ASTM D6978-05 | | | |
| Test<br>Drug | Chemotherapy | Concentration | Minimum Breakthrough Detection Time (min) | |
| Cisplatin | | 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide<br>(Cytoxan) | | 20 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) | | 10.0 mg/ml | >240 | >240 |
| Doxorubicin<br>Hydrochloride | | 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) | | 20.0 mg/ml | >240 | >240 |
| Fluorouracil | | 50.0 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) | | 6.0 mg/ml | >240 | >240 |
| Ifosfamide | | 50.0 mg/ml | >240 | - |
| Mitoxantrone | | 2.0 mg/ml | >240 | - |
| Vincristine Sulfate | | 1.0 mg/ml | >240 | - |
| *Carmustine (BCNU) | | 3.3 mg/ml | 15.0 | 18.2 |
| *Thiotepa | | 10.0 mg/ml | 2.0 | 57.3 |
| Fentanyl Citrate Injection | | 100mcg/2ml | - | >240 |
| Warning Statement | | * WARNING :<br>Please note that the<br>following drugs have<br>extremely low permeation<br>times Carmustine<br>(BCNU): 15 minutes and<br>Thiotepa : 2 minutes. | * WARNING :<br>Please note that the<br>following drugs have<br>extremely low permeation<br>times Carmustine (BCNU):<br>18.2 minutes and<br>Thiotepa : 57.3 minutes. | Similar - The<br>chemotherapy<br>drugs tested<br>have similar<br>breakthrough<br>detection<br>times; the<br>drugs with low<br>permeation<br>times are the<br>same. |

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Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Biocompatibility | Primary Skin Irritation<br>ISO 10993-10:2010<br>Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization | Passes<br>Under the conditions of the study, the subject device is non-irritating | Passes<br>Under the conditions of the study, the subject device is non-irritating | Same |
| | Dermal Sensitization<br>ISO 10993-10:2010<br>Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization | Passes<br>Under the conditions of the study, the subject device is non-sensitization | Passes<br>Under the conditions of the study, the subject device is non-sensitization | Same |
| | Cytotoxicity<br>ISO 10993-5:2009<br>Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | - | Exhibits severe cytotoxicity reactivity at 100%, and 66% extract concentrations and no cytotoxicity reactivity at 44%, 30%, 20% and 15% extract concentrations under the condition of this test. | -Different |
| | Acute systemic toxicity study<br>ISO 10993-11: 2017<br>Biological evaluation of medical devices -<br>Part 11: Tests for systemic toxicity | - | Passes<br>Under the conditions of the study, the subject showed no adverse biological reaction. | -Different |
| Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151 | Passes | Passes | Same |
| Indication for Use | | A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.<br>These gloves were | The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical | Similar |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate

| chemotherapy drugs<br>and Fentanyl Citrate<br>per ASTM D6978-05<br>(Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs.<br>Minimum Breakthrough<br>Detection Time in<br>minutes<br>Carmustine (BCNU)<br>(3.3mg/ml) - 10.1<br>Cisplatin, (1.0 mg/ml) -<br>≥ 240<br>Cyclophosphamide<br>(Cytoxan), 20.0 mg/ml<br>- ≥ 240<br>Cytarabine (100<br>mg/ml) - ≥ 240<br>Dacarbazine (DTIC),<br>10.0 mg/ml - ≥ 240<br>Doxorubicin<br>Hydrochloride, (2.0<br>mg/ml) - ≥ 240<br>Etoposide, (20.0<br>mg/ml) - ≥ 240<br>Fluorouracil, (50.0<br>mg/ml) - ≥ 240<br>Ifosfamide (50.0<br>mg/ml) ≥ 240<br>Methotrexate (25.0<br>mg/ml) ≥ 240<br>Mitomycin C (0.5<br>mg/ml) ≥ 240<br>Mitoxantrone (2.0<br>mg/ml) ≥ 240<br>Paclitaxel (Taxol), 6.0<br>mg/ml<br>- ≥ 240<br>Thiotepa (10.0 mg/ml)<br>- 30.2<br>Vincristine Sulfate (1.0<br>mg/ml) ≥ 240.<br>Please note that<br>Carmustine (BCNU)<br>has extremely low<br>permeation time of<br>10.1 minutes.<br>Fentanyl Citrate and<br>Concertation<br>Fentanyl Citrate<br>Injection (100.0<br>mcg/2ml) | purpose that is worn<br>on the examiner's<br>hand or finger to<br>prevent contamination<br>between examiner and<br>patient. In addition,<br>these gloves are worn<br>to protect the wearer<br>against exposure to<br>chemotherapy drugs<br>and Fentanyl Citrate.<br>Tested for use with<br>chemotherapy drugs<br>and Fentanyl Citrate.<br>Tested chemotherapy<br>drugs are as follows:<br>Average Breakthrough<br>Detection Time<br>(minutes)<br>Cisplatin 1.0 mg/ml ≥<br>240<br>Cyclophosphamide<br>(Cytoxan) 20 mg/ml ≥<br>240<br>Dacarbazine (DTIC)<br>10.0 mg/ml ≥ 240<br>Doxorubicin<br>Hydrochloride 2.0<br>mg/ml ≥ 240<br>Etoposide (Toposar)<br>20.0 mg/ml ≥ 240<br>Fluorouracil 50.0<br>mg/ml ≥ 240<br>Paclitaxel (Taxol) 6.0<br>mg/ml ≥ 240<br>The glove was tested<br>for use with<br>Chemotherapy Drugs<br>and Fentanyl Citrate as<br>per ASTM D6978-05<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs. Please note<br>that the following drugs<br>have extremely low<br>permeation times:<br>Carmustine (BCNU):<br>18.2 minutes and<br>Thiotepa: 57.3<br>minutes. Warning: Do<br>not use with<br>Carmustine. | | | Minimum Breakthrough<br>Detection Time in<br>minutes ≥ 240 | Tested Fentanyl<br>Citrate is as follows:<br>Average<br>Breakthrough<br>Detection Time<br>(minutes)<br>Fentanyl Citrate<br>Injection 100.0<br>mcg/2ml ≥ 240 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Material | ASTM D6319 -<br>10(2015) | Nitrile | Nitrile | Same | | |
| Color | - | Blue<br>White<br>Black | Blue | Same | | |
| Size | Medical Glove<br>Guidance Manual<br>- Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same | | |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same | | |

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Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

#### 7.0 Summary of Non-Clinical Performance Data

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

| Methodology | Purpose | Acceptance Criteria | Results |
|------------------|--------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D412-2016 | Physical Properties | Tensile Strength (Min 14 Mpa) and<br>Elongation (Min 400%) | Pass |
| ASTM D5151-2006 | Water leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-2006 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-2005 | Permeation by<br>Chemotherapy Drugs | ≥ 240 minutes | Pass |
| ISO 10993-10 | Irritation and delayed-<br>type hypersensitivity | Skin sensitization and<br>Skin irritation | The subject device is<br>non-sensitization and<br>Non-irritation |
| ISO 10993-5 | Cytotoxicity | Cytotoxicity reactivity | Exhibits severe<br>cytotoxicity reactivity at<br>100%, and 66% extract<br>concentrations and no<br>cytotoxicity reactivity at<br>44%, 30%, 20% and<br>15% extract<br>concentrations under<br>the condition of this<br>test. |
| ISO 10993-1:2018 | Acute systemic toxicity<br>study | Subject showed no adverse biological reaction | No adverse biological<br>reaction. |

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- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic o Elastomers-Tension
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes o in Medical Gloves
- O ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on Medical Gloves
- o ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of O Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo o cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and O delayed-type hypersensitivity

#### 8.0 Clinical Performance Data

Clinical data is not needed.

#### 9.0 Conclusion

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