DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

K232538 · Wrp Asia Pacific Sdn. Bhd. · LZA · Nov 17, 2023 · General Hospital

Device Facts

• Record ID: K232538
• Device Name: DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 17, 2023
• 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 or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous patient examination glove; manufactured from synthetic rubber nitrile; green inner surface and white outer surface; finger-textured. Used by clinicians to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Provides barrier protection; healthcare providers use the glove during patient examinations or handling of hazardous drugs. Benefits include reduced risk of exposure to chemotherapy agents and opioids, and prevention of patient-examiner contamination.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), watertightness (ASTM D5151), residual powder (ASTM D6124), biocompatibility (ISO 10993-10/11), and chemotherapy/fentanyl permeation (ASTM D6978-05).

Technological Characteristics

Synthetic rubber nitrile; powder-free; ambidextrous; green inner/white outer color; finger-textured. Meets ASTM D6319-19 (physical properties), ASTM D6978-05 (permeation), ASTM D5151 (watertightness), and ASTM D6124 (residual powder). Shelf life: 3 years per ASTM D7160. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with 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

• Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (K161422)

Reference Devices

• Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220375)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2023

WRP Asia Pacific Sdn. Bhd. Muhammad Ameer Arief Mohd Mujab Regulatory Affairs Executive Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang. Selangor 43900 Malaysia

Re: K232538

Trade/Device Name: Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use 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: August 1, 2023 Received: August 22, 2023

Dear Muhammad Ameer Arief Mohd Mujab:

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 (the 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 available 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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### K232538 - Muhammad Ameer Arief Mohd Mujab

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Allah G

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control

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and Plastic and Reconstructive 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) K232538

### Device Name

DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

Indications for Use (Describe)

A 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.

These gloves were 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:

| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes |
|-----------------------------------------|------------------------------------------------------------|
| *Carmustine (BCNU) (3.3 mg/ml) | 44.5 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 79.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |

* WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa.

| Opioid Drug | Breakthrough Detection Time in Minutes |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fentanyl Citrate Injection (50 mcg/ml) | No breakthrough up to 240 minutes |
| Type of Use (Select one or both, as applicable) | |
| <div style="display:flex; align-items:center;"><input style="margin-right:5px;" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" style="margin-right:5px;" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### 1.0 Submitter:

| Sponsor: | WRP Asia Pacific Sdn. Bhd. |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Muhammad Ameer Arief bin Mohd Mujab |
| Address: | WRP Asia Pacific Sdn. Bhd.<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 17 November 2023

### 2.0 Identification of the subject device:

| Trade Name | : Dual Color Nitrile Examination Gloves, Powder Free,<br>Non-Sterile, Tested For Use With Chemotherapy Drugs<br>And Fentanyl |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : I |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA, LZC, OPJ, ODO |

### 3.0 Predicate Device:

| | PREDICATE DEVICE |
|-------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device Name | Dermagrip Powder Free Blue Nitrile Patient Examination<br>Gloves, Non-sterile, Tested For Use With Chemotherapy<br>Drugs |
| Regulation Number | 21 CFR 880.6250 |
| 510 (k) Number | K161422 |
| Regulatory Class | I |
| Product Code | LZA, LZC |

#### 4.0 Reference Device:

| | REFERENCE DEVICE |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Summit Glove, Inc |
| Device name | Intercept Free, Nitrile Two Toned White/Green, Textured<br>Fingertips, Powder-Free, Non-sterile, Ambidextrous,<br>Beaded Cuff, Medical Examination Gloves, Tested for Use<br>with Opioids Fentanyl citrate, Heroin, and both Opioids in<br>simulated Gastric Acid (Vomit) |
| Regulation Number | 21 CFR 880.6250 |
| 510(k) Number | K220375 |
| Regulatory Class | I |
| Product Code | LZA, QDO |

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#### 5.0 Description of The Device:

Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19.

The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile.

The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.

#### 6.0 Indication for use:

A 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.

These gloves were 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:

| Chemotherapy Drug | Concentration | Breakthrough<br>Detection Time<br>(Minutes) |
|----------------------------|---------------|---------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 44.5 |
| Cisplatin | 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |

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| Mitoxantrone | 2.0 mg/ml | > 240 |
|---------------------|------------|-------|
| Paclitaxel | 6.0 mg/ml | > 240 |
| *ThioTepa | 10.0 mg/ml | 79.1 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa.

| Opioid Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 50mcg/mL | No breakthrough up to 240<br>minutes |

### 7.0 Comparison of Technological Characteristics Between the Subject Device and Predicate Device:

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### Table 1

| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON<br>ANALYSIS |
|-----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 510(k) Number | - | K161422 | K220375 | K232538 | - |
| Manufacturer(s) | - | WRP Asia Pacific | Summit Glove, Inc | WRP Asia Pacific | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Nitrile | Same |
| Color | - | Blue | Outer: White<br>Inner: Green | Outer: White<br>Inner: Green | Same with<br>reference device |
| Texture | - | Finger Textured | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319 | Meets | Meets | Meets | Same |
| Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | - | 14Mpa min<br>500% min | 30 ± 0.03 Mpa<br>600% min | 14MPa min<br>500% min | Same |
| After Aging<br>Tensile Strength:<br>Ultimate Elongation: | - | 14Mpa min<br>400% min | 32 ± 0.03 Mpa<br>550% | 14Mpa min<br>400% min | Same |
| Thickness:<br>- Finger<br>- Palm | ASTM D6319 | Meets<br>0.07 - 0.10mm<br>0.07 – 0.09mm | Meets<br>0.21 ± 0.03 mm<br>0.16 ± 0.03 mm | Meets<br>0.20 ± 0.03 mm<br>0.16 ± 0.03 mm | Different but<br>within the ASTM<br>standard |
| Powder Free | ASTM D6124 | Less than 2mg per<br>glove | Less than 2mg per<br>glove | Less than 2mg per<br>glove | Same |
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON<br>ANALYSIS |
| Biocompatibility | Primary Skin<br>Irritation - ISO<br>10993-10:2010<br>(E) | Passes<br>Not a primary skin<br>irritant under the<br>conditions of the study | Passes<br>Not a primary skin<br>irritant under the<br>conditions of the study | Passes<br>Not a primary skin<br>irritant under the<br>conditions of the study | Same |
| | Dermal<br>Sensitization-<br>ISO 10993-10:<br>2010 (E) | Passes<br>Not a contact sensitizer<br>under the conditions of<br>the study. | Passes<br>Not a contact<br>sensitizer under the<br>conditions of the<br>study. | Passes<br>Not a contact<br>sensitizer under the<br>conditions of the<br>study. | Same |
| | Acute Systemic<br>Toxicity, ISO<br>10993-11:2017<br>(E) | Passes<br>It is concluded that the<br>product did not induce<br>any systemic toxicity. | Passes<br>It is concluded that<br>the product did not<br>induce any systemic<br>toxicity. | Passes<br>It is concluded that<br>the product did not<br>induce any systemic<br>toxicity. | Same |
| Watertight<br>(1000ml) | ASTM D5151 | Inspection Level 1, AQL<br>1.5 | Inspection Level 1,<br>AQL 0.65 | Inspection Level 1,<br>AQL 1.5 | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS |
| | | PREDICATE | REFERENCE | CURRENT | |
| 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. | 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. | 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. | Same |
| Size | Medical Glove<br>Guidance Manual<br>– Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Small<br>Medium<br>Large<br>Extra Large<br>Double Extra Large<br>Triple Extra Large | Small<br>Medium<br>Large<br>Extra Large<br>Double Extra Large | Similar |
| Single use | Medical Glove<br>Guidance Manual<br>- Labeling | Single use | Single use | Single use | Same |
| Sterility status | Medical Glove<br>Guidance Manual<br>– Labeling | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf life | ASTM D7160 | | 5 years | 3 years | Different |
| Chemotherapy<br>Drug Permeation<br>Test | ASTM D6978-<br>05 | Minimum Breakthrough Detection Time (Minutes) | | | |
| * Carmustine<br>(BCNU)<br>(3.3 mg/ml) | | 15.0 | N/A | 44.5 | Similar |
| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
| Cisplatin (1.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Dacarbazine (10.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Etoposide (20.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Fluorouracil (50.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Ifosfamide (50.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Methotrexate (25.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Mitomycin C (0.5 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Mitoxantrone (2.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| Paclitaxel (6.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |
| * ThioTepa (10.0 mg/ml) | 2.0 | 2.0 | N/A | 79.1 | Similar |
| Vincristine Sulfate (1.0 mg/ml) | > 240 | > 240 | N/A | > 240 | Same |

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| CHARACTERISTICS | STANDARDS | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
|-------------------------------------------------|-----------|---------------------------------------------------------------------------------------------------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Warning Statement | | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 15.0 minutes and Thiotepa: 2.0 | N/A | WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa. | Similar |
| Fentanyl Citrate | | N/A | > 240 | > 240 | Same with reference device |
| Fentanyl + Heroin | | N/A | > 240 | N/A | Different |
| Fentanyl + Heroin in simulated Gastric Acid Mix | | N/A | > 240 | N/A | Different |

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There are no significant differences between the devices. Both devices have been tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05.

They are slightly different in thickness; whereby the current device is thicker than the predicate device. Predicate device comes in blue color whereas the subject device comes in a combination of fluoresced green (inner part) and white (outer part) color. Other differences noted, subject device was tested for Fentanyl Citrate which accords to ASTM D6978-05.

#### 8.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this Glove are summarized as per below.

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| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | | Results | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------|-----------------|-----------------|-------------|------|
| | | | Before aging | After aging | Before aging | After aging | |
| Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized<br>Rubber and<br>Thermoplastic<br>Elastomers-<br>Tension) | To<br>evaluate<br>the tensile<br>(tension)<br>properties<br>of glove. | Tensile<br>strength | Min 14.0<br>MPa | Min 14.0<br>MPa | Pass | Pass |
| | | | Ultimate<br>elongation | Min 500% | Min 400% | Pass | Pass |

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimension | ASTM D3767<br>Standard Practice<br>for Rubber -<br>Measurement of<br>Dimensions | To measure<br>the length,<br>width, and<br>thickness of<br>glove | Length<br>Small - Min 220 mm<br>Medium - Min 230 mm<br>Large - Min 230 mm<br>Extra Large - Min 230 mm<br>Double Extra Large - Min 230 mm | Pass |
| | | | Width<br>Small - 80 $\pm$ 10 mm<br>Medium - 95 $\pm$ 10 mm<br>Large - 110 $\pm$ 10 mm<br>Extra Large - 120 $\pm$ 10 mm<br>Double Extra Large - 130 $\pm$ 10 mm | Pass |

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| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------|---------|
| Dimension | ASTM D3767<br>Standard Practice<br>for Rubber -<br>Measurement of<br>Dimensions | To measure<br>the length,<br>width, and<br>thickness of<br>glove | Thickness<br>Finger – min 0.05mm<br>Palm – min 0.05mm | Pass |

{16}------------------------------------------------

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|----------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------|
| Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves) | To detect holes that<br>leak water and<br>thereby compromise<br>the usefulness of the<br>glove | Size: Small<br>Sample size: 200 pcs<br>Inspection level: GI<br>AQL: 1.5, Acceptance No. 7,<br>Found 0 | Pass |
| | | | Size: Medium<br>Sample size: 315 pcs<br>Inspection level: GI<br>AQL: 1.5, Acceptance No. 10,<br>Found 0 | Pass |
| | | | Size: Large<br>Sample size: 315 pcs<br>Inspection level: GI<br>AQL: 1.5, Acceptance No. 10,<br>Found 0 | Pass |
| | | | Size: Extra Large<br>Sample size: 315 pcs<br>Inspection level: GI<br>AQL: 1.5, Acceptance No. 10,<br>Found 0 | Pass |
| | | | Size: Double Extra Large<br>Sample size: 200 pcs<br>Inspection level: GI<br>AQL: 1.5, Acceptance No. 7,<br>Found 0 | Pass |

{17}------------------------------------------------

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|--------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------|---------|
| Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for<br>Residual Powder<br>on Medical Gloves) | To determine the<br>amount of residual<br>powder and non-<br>powder solids found<br>on gloves | Have a powder residue limit of 2.0 mg per<br>glove | Pass |

| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results |
|------------------|--------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------|---------|
| Biocompatibility | Primary Skin<br>Irritation - ISO<br>10993-10 (E) | To assess the potential<br>of glove to produce<br>dermal irritation | Under the conditions of the study, not<br>an irritant | Pass |
| Biocompatibility | Dermal<br>Sensitization- ISO<br>10993-10 (E) | To assess the potential<br>of glove to cause<br>dermal sensitization | Under the conditions of the study, not<br>a sensitizer | Pass |
| Biocompatibility | Acute Systemic<br>Toxicity, ISO<br>10993-11 (E) | To determine the acute<br>systemic toxicity<br>potential of glove | Under the conditions of the study, no<br>acute systemic toxicity | Pass |

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| Test Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemotherapy<br>Drug and Fentanyl<br>Citrate<br>Permeation | ASTM D6978-05<br>(Assessment of<br>Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs) | To assess the<br>resistance of<br>medical glove<br>materials to<br>permeation by<br>chemotherapy<br>drugs and<br>fentanyl<br>citrate | Minimum<br>breakthrough time<br>>240min | Carmustine 3.3 mg/ml<br>Cisplatin 1 mg/ml<br>Cyclophosphamide 20 mg/ml<br>Dacarbazine 10 mg/ml<br>Doxorubicin HCI 2 mg/ml<br>Etoposide 20 mg/ml<br>Fluorouracil 50 mg/ml<br>Ifosfamide 50 mg/ml<br>Methotrexate 25 mg/ml<br>Mitoxantrone HCI 2 mg/ml<br>Paclitaxel 6 mg/ml<br>Thiotepa 10 mg/ml<br>Vincristine Sulfate 1 mg/ml<br>Fentanyl Citrate 50 mcg/ml | 44.5 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>>240 min<br>79.1 min<br>>240 min<br>>240 min |

The shelf-life study claim of this Glove describes the effect of accelerated aging on visual appearance, hole defect and physical properties for establishing a 3 years shelf life based on ASTM D7160.

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#### 9.0 Summary of Clinical Testing:

No clinical study is included in this submission.

#### 10.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl is as safe, as effective, and performs as well as or better than the legally marketed predicate device K161422.