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

K232064 · Isikel Manufacturing, LLC · LZA · Oct 2, 2023 · General Hospital

Device Facts

• Record ID: K232064
• Device Name: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
• Applicant: Isikel Manufacturing, LLC
• Product Code: LZA · General Hospital
• Decision Date: Oct 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous, powder-free nitrile examination gloves; manufactured from 100% nitrile-butadiene copolymer dispersion. Designed for use by healthcare professionals in clinical settings to prevent cross-contamination. Features textured fingers for grip. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Output is a physical barrier; healthcare providers use the gloves during patient examinations or handling of hazardous drugs. Benefits include protection against patient-to-examiner contamination and exposure to tested chemical agents. Warning provided for specific drugs (Carmustine, Thiotepa) with lower breakthrough times.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319-19 (physical dimensions, tensile strength, elongation, watertightness, residual powder) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-5, 10, 11, and 23.

Technological Characteristics

Material: 100% nitrile-butadiene copolymer. Form factor: Ambidextrous, textured fingers, blue color. Standards: ASTM D6319-19 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151 (watertightness), ASTM D6124 (residual powder). Sterilization: Non-sterile. Connectivity: None.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands to prevent cross-contamination between patient and examiner. 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

• Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (K211810)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

October 2, 2023

Isikel Manufacturing LLC % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K232064

Trade/Device Name: Powder-Free Frost Nitrile Examination Gloves (Blue) (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: July 10, 2023 Received: July 11, 2023

Dear Yolanda Smith:

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/cdrb/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 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.

# Allan Gu

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control 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) K232064

#### Device Name

Powder-Free Frost Nittile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate)

#### Indications for Use (Describe)

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration |
|----------------------------|-----------------------|
| Carmustine | 3.3 mg/ml (3,300 ppm) |
| Cisplatin | 1 mg/ml (1,000 ppm) |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) |
| Dacarbazine | 10 mg/ml (10,000 ppm) |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) |
| Etoposide | 20 mg/ml (20,000 ppm) |
| Fluorouracil | 50 mg/ml (50,000 ppm) |
| Mitomycin C | 0.5 mg/ml (500 ppm) |
| Paclitaxel | 60 mg/ml (6,000 ppm) |
| Thiotepa | 10 mg/ml (10,000 ppm) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) |
| Fentanyl/Citrate Injection | 100 mcg/2mL |

Breakthrough Detection Time 16.2 (16.2,21.6,21.9) min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. 40.6 (70.6,40.6,40.6) min. >240 min. >240min.

Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 minutes Warning: Do Not Use with Carmustine and Thiotepa

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Submitter's Information | |
|-------------------------|----------------------------------------|
| Company: | Isikel Manufacturing LLC. |
| Address: | 28350 West Ten Blvd.<br>Katy, TX 77494 |
| Phone: | 832-523-2027 |
| Contact: | Christopher Betts |
| Email: | [e-mail] |
| Date Prepared: | October 2, 2023 |

| Designated Submission Correspondent | |
|-------------------------------------|------------------------------------------|
| Name | Yolanda Smith |
| Company: | Smith Associates |
| Address: | 1468 Harwell Avenue<br>Crofton, MD 21114 |
| Phone | 888-729-9674 x 203 |
| Email: | [e-mail] |

| Email: | [e-mail] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Information and Name | |
| Trade Name: | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
| Common Name: | Patient Examination Gloves, Specialty |
| Classification Name: | Polymer Patient Exam Glove, Medical Gloves with Chemotherapy Labeling Claims |
| Product Code: | LZA- Polymer Patient Examination Glove |
| Product Code: | LZC- Patient Examination Glove, Specialty |
| Product Code: | OPJ- Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Product Code | QDO - Fentanyl And Other Opioid Protection Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I, Reserved |
| Reviewing Panel: | General Hospital |
| Basis for Submission: | New Device 510(k) |

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| Predicate Device K211810 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Manufacturer | PT. Shamrock Manufacturing Corporation |
| Device Name | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for<br>use with Chemotherapy Drugs and Fentanyl Citrate) |
| Regulation No.<br>Regulation Name | 21 CFR 880.6250<br>Non-Powdered Patient Examination Glove |
| 510 (K) Number | K211810 |
| Regulatory Class | 1 |
| Product Code | LZA, LZC, OPJ, QDO |

## 1. Device Description

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).

## 2. Indications for Use

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.

| Tested Chemotherapy Drug<br>Name | Concentration | Breakthrough Detection Time |
|----------------------------------|-----------------------|-----------------------------|
| Carmustine | 3.3 mg/ml (3,300 ppm) | 16.2 (16.2.21.6,21.9) min. |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |

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| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
|----------------------------|-----------------------|----------------------------|
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. |
| Paclitaxel | 60 mg/ml (6,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 40.6 (70.6,40.6,40.6) min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Fentanyl/Citrate Injection | 100mcg / 2mL | >240 min. |

Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 Minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 Minutes Warning: Do Not Use with Carmustine and Thiotepa

| Characteristics | Subject Device | Predicate Device<br>K211810 | Comparison |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| K Number | | K211810 | |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Indications for use | Powder-Free Frost Nitrile<br>Examination Gloves (Blue)<br>(Tested for use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate) is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hands to<br>prevent contamination<br>between patient and examiner.<br>In addition, these gloves were<br>tested for use with<br>Chemotherapy drugs and<br>Fentanyl Citrate in<br>accordance with ASTM<br>D6978-05<br>Carmustine 3.3 mg/ml (3,300<br>ppm)<br>16.2 (16.2.21.6,21.9) min.<br>Cisplatin<br>1 mg/ml (1,000 ppm)<br>>240 min. | A patient examination glove<br>is a disposable device<br>intended for medical purpose<br>that is worn on examiner's<br>hand to<br>prevent contamination<br>between patient and<br>examiner. These gloves were<br>tested for use with<br>Chemotherapy Drugs as per<br>ASTM D6978-05(2019)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs and<br>Fentanyl. The following<br>chemicals have been tested<br>with these gloves:<br>Chemotherapy Drug and<br>Concentration Breakthrough<br>Detection Time in Minutes<br>Carboplatin (Paraplatin), 10<br>mg/ml (10,000ppm) > 240<br>min. | Same for<br>indications<br>for use<br>statement and<br>for all<br>comparative<br>chemotherapy<br>drugs. |
| Characteristics | Subject Device | Predicate Device<br>K211810 | Comparison |
| | Cyclophosphamide 20<br>mg/ml (20,000 ppm)<br>>240 min.<br>Dacarbazine 10 mg/ml<br>(10,000 ppm)<br>>240 min.<br>Doxorubicin HCL 2 mg/ml<br>(2,000 ppm)<br>>240 min.<br>Etoposide 20 mg/ml (20,000<br>ppm)<br>>240 min.<br>Fluorouracil 50 mg/ml<br>(50,000 ppm)<br>>240 min.<br>Mitomycin C 0.5 mg/ml (500<br>ppm)<br>>240 min.<br>Paclitaxel 60 mg/ml (6,000<br>ppm)<br>>240 min.<br>Thiotepa 10 mg/ml (10,000<br>ppm)<br>40.6 (70.6,40.6,40.6) min.<br>Vincristine Sulfate 1 mg/ml<br>(1,000 ppm)<br>>240 min.<br>Fentanyl/Citrate Injection<br>100mcg / 2mL >240 min.<br>Please note the following<br>drugs have low permeation<br>times:<br>Carmustine 3.3 mg/ml (3,300<br>ppm) 16.2(16.2.21.6,21.9)<br>Minutes<br>Thiotepa 10 mg/ml (10,000<br>ppm) 40.6 (70.6,40.6,40.6)<br>Minutes<br>Warning: Do Not Use with<br>Carmustine and Thiotepa | Carmustine (BCNU), 3.3<br>mg/ml (3,300ppm) 46.6 min.<br>Chloroquine 50mg/ml<br>(50,000ppm) > 240 min<br>Cisplatin, 1.0 mg/ml<br>(1,000ppm) > 240 min<br>Cyclophosphamide<br>(Cytoxan), 20.0mg/ml<br>(20,000 ppm) > 240 min<br>Dacarbazine, 10.0mg/ml<br>(10,000ppm) > 240 min<br>Docetaxel, 10mg/ml<br>(10,000ppm) > 240 min<br>Doxorubicin HCI, 2.0mg/ml<br>(2,000ppm) > 240 min<br>Etoposide, 20.0mg/ml<br>(20,000ppm) > 240 min<br>Fluorouracil, 50.0mg/ml<br>(50,000ppm) > 240 min<br>Ifosfamide, 50 mg/ml (50,000<br>ppm) > 240 min<br>Methotrexate, 25mg/ml<br>(25,000 ppm) > 240 min<br>Mitomycin C, 0.5 mg/ml (500<br>ppm) > 240 min<br>Paclitaxel, 6.0 mg/ml (6,000<br>ppm) > 240 min<br>Thiotepa, 10.0mg/ml<br>(10,000ppm) 64.8 min<br>Vincristine Sulfate, 1 mg/ml<br>(1,000 ppm) > 240 min<br>Fentanyl Citrate Injection<br>100mcg/2ml (50mcg/1ml) ><br>240 min<br>Please note that the following<br>drugs that have low<br>permeation time are:<br>Carmustine (BCNU), 3.3<br>mg/ml 46.6 min<br>Thiotepa, 10.0mg/ml 64.8<br>min<br>CAUTION: Testing showed<br>an average of breakthrough<br>time of 46.6 min for<br>Carmustine and 64.8 min for<br>Thiotepa. | |
| Powdered or Powder<br>free | Powder free | Powder free | Same |
| Material | Nitrile | Nitrile | Same |
| Characteristics | Subject Device | Predicate Device<br>K211810 | Comparison |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Color | Light Blue | Blue | Similar |
| Size | Small, Medium, Large, Extra<br>Large | X-Small, Small, Medium,<br>Large, X-Large, XX-large | Similar |
| Single Use vs<br>Reusable | Single use | Single use | Same |
| Residual Powder | Powder Free<br><=2 mg/glove<br>Complies with ASTM D6319-<br>19 | Powder Free<br><=2 mg/glove<br>Complies with ASTM D6319-19 | Same |
| Detection of Holes<br>ASTM D5151-2019 | AQL 2.5<br>Complies with ASTM D6319-<br>19 | AQL 2.5<br>Complies with ASTM D6319-19 | Same |
| Dimensions<br>(Length, Width,<br>Thickness) | Complies with ASTM D6319-<br>19 | Complies with ASTM D6319-19 | Same |
| Physical Properties<br>(Unaged) | Elongation: 500% min.<br>Tensile Strength: 14MPa min.<br>Complies with ASTM D6319-<br>19 | Elongation: 500% min.<br>Tensile Strength: 14MPa min.<br>Complies with ASTM<br>D6319-19 | Same |
| Physical Properties<br>(Aged) | Elongation: 400% min.<br>Tensile Strength: 14MPa min.<br>Complies with ASTM D6319-<br>19 | Elongation: 400% min.<br>Tensile Strength: 14MPa min.<br>Complies with ASTM<br>D6319-19 | Same |
| Labeling<br>Information<br>FDA Label<br>Requirements | Meets FDA's Requirements | Meets FDA's Requirements | Same |

# 3. Summary of the Technological Characteristics of the Device compared to its Predicate

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| Test Method | ASTM D6319-19 | | | | Comparison of<br>Test results | | |
|------------------------|----------------------------------------------------------------|-------|-------|-------|-------------------------------|------|--------------|
| Purpose | To Determine the Length of Gloves | | | | | | |
| Acceptance Criteria | Min 220 mm for all Size Small & Min 230 mm for all other sizes | | | | | | |
| Designation-<br>Length | S | M | L | XL | Tolerance | | |
| Subject<br>Device | Length, mm | 220mm | 230mm | 230mm | 230mm | min. | Met Standard |
| Predicate<br>K211810 | Length, mm | 220mm | 230mm | 230mm | 230mm | min. | Met Standard |

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| Test Method | ASTM D6319-19 | | | | Comparison of Test results | | |
|---------------------|---------------------------------------------------------------------------------------|------|------|-------|----------------------------|-------------|--------------|
| Purpose | To Determine the Width of Gloves | | | | | | |
| Acceptance Criteria | Small: 80+/110 mm<br>Medium: 95+/- 10mm<br>Large: 110+/- 10mm<br>X Large: 115+/1 10mm | | | | | | |
| Designation- Width | S | M | L | XL | Tolerance | | |
| Subject Device | Width, mm | 80mm | 95mm | 110mm | 115mm | $\u00b1$ 10 | Met Standard |
| Predicate K211810 | Width, mm | 80mm | 95mm | 110mm | 115mm | $\u00b1$ 10 | Met Standard |

| Test Method | ASTM D6319-2019 | | | | Comparison of Test results | |
|----------------------|------------------------------------------------|--------------|--------------|--------------|----------------------------|----------------|
| Purpose | To Determine the Palm Thickness of the Glove | | | | | |
| Acceptance Criteria | Palm 0.05 mm min for all sizes | | | | | |
| Designation- Palm | S | M | L | XL | | |
| Subject | Palm | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Predicate<br>K211810 | Palm | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Purpose | To Determine the Finger Thickness of the Glove | | | | | |
| Acceptance Criteria | Finger 0.05 mm min for all sizes | | | | | |
| Designation - Finger | S | M | L | XL | | |
| Subject | Finger | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Predicate<br>K211810 | Finger | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |

| Test Method | ASTM D412 | Comparison of Test results | |
|-------------------------------------|----------------------------------------------------------------------------|------------------------------------------------|----------------------------|
| Purpose | Test Method for Vulcanized Rubber and Thermoplastic Elastomers-<br>Tension | | |
| Acceptance Criteria<br>Before Aging | Tensile Strength- Before Aging<br>14 MPa, min | Ultimate Elongation- Before Aging<br>500 % min | |
| Subject | $\geq$ 14 MPa | 500% | Same |
| Predicate | $\geq$ 14 MPa | 500% | Same |
| K211810 | | | |
| Test Method | ASTM D412 | | Comparison of Test results |

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| Purpose | Test Method for Vulcanized Rubber and Thermoplastic Elastomers-<br>Tension | | |
|------------------------------------|----------------------------------------------------------------------------|----------------------------------------------|------|
| Acceptance Criteria<br>After Aging | Tensile Strength- After Aging<br>14 MPa, min | Ultimate Elongation- After Aging<br>400% min | |
| Subject | $\u2265$ 14 MPa | 400% | Same |
| Predicate<br>K211810 | $\u2265$ 14 MPa | 400% | Same |

| Tested Chemotherapy<br>Drug Name | Concentration | Subject Device | Predicate Device<br>211810 | Comparison |
|----------------------------------|--------------------------|-----------------------------------|----------------------------|------------|
| Carmustine | 3.3 mg/ml<br>(3,300 ppm) | 16.2 min<br>(16.2. 21.6,<br>21.9) | 46.6 Minutes | Different |
| Cisplatin | 1 mg/ml (1,000<br>ppm) | >240 min. | >240 Minutes | Same |
| Cyclophosphamide | 20 mg/ml<br>(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Dacarbazine | 10 mg/ml<br>(10,000 ppm) | >240 min. | >240 Minutes | Same |
| Doxorubicin HCL | 2 mg/ml (2,000<br>ppm) | >240 min. | >240 Minutes | Same |
| Etoposide | 20 mg/ml<br>(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Fluorouracil | 50 mg/ml<br>(50,000 ppm) | >240 min. | >240 Minutes | Same |
| Mitomycin C | 0.5 mg/ml (500<br>ppm) | >240 min. | >240 Minutes | Same |
| Paclitaxel | 60 mg/ml (6,000<br>ppm) | >240 min. | >240 Minutes | Same |
| Thiotepa | 10 mg/ml<br>(10,000 ppm) | 40.6 min<br>(70.6,40.6,40.6) | 64.8 Minutes | Different |
| Vincristine Sulfate | 1 mg/ml (1,000<br>ppm) | >240 min. | >240 Minutes | Same |
| Fentanyl/Citrate<br>Injection | 100mcg / 2mL | >240 min. | >240 Minutes | Same |

| Test Method | Purpose of Test | Subject Device | Predicate | Comparison of Test results |
|---------------|-----------------------------------------------------------------------|------------------------------|---------------------------------|----------------------------|
| ASTM D6319-19 | Physical Dimensions<br>To determine the Length<br>and Width of Gloves | Complies with: ASTM D6319-19 | Complies with:<br>ASTM D6319-19 | Same |

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| Test<br>Method | Purpose of Test | Subject Device | Predicate | Comparison<br>of Test results |
|------------------|-----------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------|
| ASTM<br>D5151 | Watertightness Test for<br>Detection of Holes | Meets the requirement<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL = 2.5 | Complies with:<br>ASTM D6319-<br>19 ASTM<br>D5151<br>AQL 2.5 | Same |
| ASTM<br>D6124-06 | To determine the residual<br>powder in gloves | Meets the requirement<br>of ASTM D6124 $<$ 2<br>mg glove | Complies with:<br>ASTM D6319-<br>19<br>$<$ 2 mg per<br>glove | Same |

| Test Performed | Subject Device | Predicate Device<br>K211820 | Comparison |
|-----------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------|------------|
| ISO 10993-10:2010<br>Skin Sensitization Test | Non-Sensitizer | Under the conditions<br>of study, not a<br>sensitizer | Same |
| ISO 10993-23:2021<br>Intracutaneous Reactivity Test | Non-Irritant | Under the conditions<br>of study, not an<br>irritant | Same |
| ISO 10993-5:2009<br>In vitro Cytotoxicity Test | Under the<br>conditions of the<br>study, cytotoxic. | Under the<br>conditions of the<br>study, cytotoxic | Same |
| ISO 10993-11:2017<br>Acute Systemic Toxicity Test | Pass | Under the conditions<br>of study, does not<br>induce any acute<br>systemic<br>toxicity concern | Same |

Analysis: Some of the sizes are different with that of the predicate, but they all meet the requirements of ASTM D6319-19. The differences do not raise any new safety or performance issues. Differences in breakthrough detection times are addressed through labeling.

### 4. Discussion of Non-Clinical Performance Testing

Non-Clinical test were conducted to verify that the proposed device met all design specifications.

### Biocompatibility Testing

ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices. Part 10- Test for Irritation and Skin Sensitization.

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ISO 10993-11 ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

ISO 10993-23:2021 Biological Evaluation of Medical Devices, Part 23: Tests for Irritation-Primary

# Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the label claim: Tested for use with Chemotherapy drugs and Fentany] Citrate. The proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted in accordance with the following test methods:

- ASTM D6319-19 Standard Specifications for Nitrile Examination Gloves for Medical Application.
- o ASTM D412-Test methods for Vulcanized Rubber and Thermoplastic Elastomers- Tension.
- o ASTM D573-Test Method for Rubber-Deterioration in an Air Oven.
- o ASTM D3767- Practice Rubber Examination Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical о Gloves
- 0 ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6978-05- Standard Practice for Assessment of Resistance of Medical Gloves to . Permeations by Chemotherapy Drugs.

| Physical Properties -Tensile Strength<br>Before and After Aging | Acceptance Criteria- For all Sizes<br>Before and After Aging 14Mpa | | |
|-----------------------------------------------------------------|--------------------------------------------------------------------|-------------|------------------------------------------------------|
| Test Method - Applicable Standard | Before Aging | After Aging | Unexpected<br>Results –<br>Significant<br>Deviations |

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| ASTM D412 | 19.0 min (MPa) | 22.6 min<br>(MPa) | None |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------|------------------------------------------------------|
| Physical Properties-Ultimate Elongation<br>Before and After Aging<br>Acceptance Criteria- For All Sizes<br>Before Aging 500% - After Aging 400% | | | |
| Test Method - A…