Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

K193666 · Medline Industries, Inc. · LZA · Aug 4, 2020 · General Hospital

Device Facts

• Record ID: K193666
• Device Name: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
• Applicant: Medline Industries, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Aug 4, 2020
• 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 to prevent contamination between patient and examiner.

Device Story

Non-sterile, powder-free, ambidextrous nitrile examination gloves; available in regular and extended cuff lengths. Designed to prevent cross-contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Used in clinical settings by healthcare professionals. Provides a barrier against chemical exposure during handling of hazardous drugs. Output is the physical barrier provided by the glove material.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-10, ISO 10993-11), physical dimensions (ASTM D6319-10), freedom from holes (ASTM D5151-06), residual powder (ASTM D6124-06), and chemotherapy/Fentanyl permeation testing (ASTM D6978-05). Cytotoxicity testing (ISO 10993-5) failed.

Technological Characteristics

Material: Powder-free nitrile. Form factor: Ambidextrous, beaded cuff, blue color. Dimensions: Compliant with ASTM D6319-10. Sterilization: Non-sterile. Connectivity: None. Sensing/Actuation: None (passive barrier).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand 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

• YTY Industry (Manjung): Non-Sterile, Powder-Free Nitrile Examination Gloves (Cobalt Blue) Tested for use with Chemotherapy Drugs (K111248)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

August 4, 2020

Leontyne Banks Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K193666

Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) - Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) -Extended Cuff Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ Dated: June 10, 2020 Received: June 10, 2020

Dear Leontyne Banks:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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)

#### K193666

#### Device Name

Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff

Indications for Use (Describe)

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

| Chemo Drugs Tested: | Breakthrough Time (Minutes) |
|----------------------------------------------------|--------------------------------|
| Aresenic Trioxide 1 mg/ml (1,000 ppm) | >240 |
| Azacitidine 25 mg/ml (25,000 ppm) | >240 |
| Bendamustine 5 mg/ml (5,000 ppm) | >240 |
| Bleomycin 15 mg/ml (15,000 ppm) | >240 |
| Bortezomib 1 mg/ml (1,000 ppm) | >240 |
| Busulfan 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin 10.0 mg/ml (10,000 ppm) | >240 |
| Carfilzomib 2.0 mg/ml (2,000) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 33.1 min |
| Cetuximab 2.0 mg/ml (2,000) | >240 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | >240 |
| Cytarabine 100 mg/ml (100,000 ppm) | >240 |
| Cytovene 10 mg/ml (10,000 ppm) | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 |
| Daunorubicin 5 mg/ml (5,000 ppm) | >240 |
| Decitabine 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel 10.0 mg/ml (10,000 ppm) | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 |
| Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 |
| Fludarabine 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 |
| Fulvestrant 50.0 mg/ml (50,000 ppm) | >240 |
| Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | >240 |
| Idarubicin 1 mg/ml (1,000 ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 |
| Irinotecan 20.0 mg/ml (20,000 ppm) | >240 |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Melphalan 5 mg/ml (5,000 ppm) | >240 |
| Methotrexate 25 mg/ml (25,000 ppm) | >240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | >240 |
| Oxaliplatin 2.0 mg/ml (2,000 ppm) | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 |
| Paraplatin 10 mg/ml (10,000 ppm) | >240 |
| Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) | >240 |
| Pertuzumab 30 mg/ml (30,000 ppm) | >240 |
| Raltitrexed 0.5 mg/ml (500 ppm) | >240 |
| Retrovir 10.0 mg/ml (10,000 ppm) | >240 |
| Rituximab 10 mg/ml (10,000 ppm) | >240 |
| Temsirolimus 25.0 mg/ml (25,000 ppm) | >240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 69.2 min |
| Topotecan HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Trastuzumab 21.0 mg/ml (21,000 ppm) | >240 |
| Trisonex 1 mg/ml (1,000 ppm) | >240 |
| Vinblastine 1 mg/ml (1,000 ppm) | >240 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 |
| Vinorelbine 10 mg/ml (10,000 ppm) | >240 |
| Zoledronic Acid 0.8 mg/ml (800 ppm) | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |
| Chemotherapy Drug Tested | Breakthrough Time (in minutes) |
| Aresenic Trioxide 1 mg/ml | >240 |
| Azacitidine 25 mg/ml | >240 |
| Bendamustine 5 mg/ml | >240 |
| Bleomycin 15 mg/m | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carfilzomib 2 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 59.4 min |
| Cetuximab | >240 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine Hydrochloride 100 mg/ml | >240 |
| Cytovene 10 mg/ml | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Decitabine 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Epirubicin (Ellence) 2.0 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50.0 mg/ml | >240 |
| Fulvestrant 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50.0 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25.0 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2mg/ml | >240 |
| Oxaliplatin 5.0 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin (Carboplatin) 10 mg/ml | >240 |
| Pemetrexed Disodium 25.0 mg/ml | >240 |
| Pertuzumab 30 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Retrovir 10.0 mg/ml | >240 |
| | |
| Rituximab 10 mg/ml | >240 |
| Temsirolimus 25.0 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 68.2 min |
| Topotecan HCI 1.0 mg/ml | >240 |
| Trastuzumab 21.0 mg/ml | >240 |
| Trisonex 1 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Zoledronic Acid 0.8 mg/ml | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |

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Please note that the following drug has low permeation time:

Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes

Thiotepa (THT) (10.0mg/ml) 69.2 minutes

CAUTION: Testing showed an average breakthrough time of 33.1 minutes with Carmustine and 69.2 minutes with 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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# Indications for Use

#### 510(k) Number (if known) K193666

#### Device Name

Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

Indications for Use (Describe)

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

{5}------------------------------------------------

Please note that the following drug has low permeation time:

Carmustine (BCNU) (3.3 mg/ml) 59.4 minutes

Thiotepa (THT) (10.0 mg/ml) 68.2 minutes

CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. A white, stylized cross is prominently displayed, with the word "MEDLINE" in white, bold letters superimposed over the center of the cross. A small gray rectangle is visible in the upper right corner of the image.

hree Lakes Drive Northfield. IL 60093

# 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

# Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 Applicant Contact: Leontyne Banks Regulatory Affairs Specialist

Summary Preparation Date

July 31, 2020

# Type of 510(k) Submission

Traditional

# Device Name / Classification

Name of Device: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

Proprietary Name: Medline Powder-Free Blue Nitrile Patient Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Regular Cuff; Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff Common Name: Patient Examination Glove, Specialty

Classification Name: Polymer Patient Exam Glove, Medical Gloves with Chemotherapy/Fentanyl Labeling Claims

Product Code: LZA, OPJ, QDO Classification Panel: General Hospital Regulation #: 21 CFR 880.6250

# Predicate Device

YTY Industry (Manjung): Non-Sterile, Powder-Free Nitrile Examination Gloves (Cobalt Blue) Tested for use with Chemotherapy Drugs - K111248

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Image /page/7/Picture/0 description: The image is a logo for Medline. The logo is set against a blue background. The word "MEDLINE" is in white, bold, sans-serif font. A white star-like symbol is behind the word "MEDLINE".

Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

## Device Description

The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) - Extended Cuff are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in two versions: Regular cuff (VS311) and Extended cuff (VS711).

| Model Number | Size |
|--------------|-------------|
| VS311XS | Extra-Small |
| VS311S | Small |
| VS311M | Medium |
| VS311L | Large |
| VS311XL | Extra-Large |

#### TABLE 1: The Medline Powder-Free Blue Nitrile Examination Gloves – Regular Cuff Sizes

#### TABLE 2: The Medline Powder-Free Blue Nitrile Examination Gloves – Extended Cuff Sizes

| Model Number | Size |
|--------------|-------------|
| VS711XS | Extra-Small |
| VS711S | Small |
| VS711M | Medium |
| VS711L | Large |
| VS711XL | Extra-Large |

The gloves are designed and manufactured in accordance with the ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs as well as for use with Fentanyl per ASTM D6978-05 (Reapproved 2019).

# Indications for Use - Regular Cuff (VS311XS, VS311S, VS311M, VS311L and VS311XL)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested

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Image /page/8/Picture/0 description: The image is a square logo for Medline. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters, and a white star-like symbol is above and below the word. The star symbol has four points, with the top and bottom points being longer than the side points.

for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

| Chemo Drugs Tested: | Breakthrough Time (Minutes) |
|----------------------------------------------------|-----------------------------|
| Aresenic Trioxide 1 mg/ml (1,000 ppm) | >240 |
| Azacitidine 25 mg/ml (25,000 ppm) | >240 |
| Bendamustine 5 mg/ml (5,000 ppm) | >240 |
| Bleomycin 15 mg/ml (15,000 ppm) | >240 |
| Bortezomib 1 mg/ml (1,000 ppm) | >240 |
| Busulfan 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin 10.0 mg/ml (10,000 ppm) | >240 |
| Carfilzomib 2.0 mg/ml (2,000) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 33.1 min |
| Cetuximab 2.0 mg/ml (2,000) | >240 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | >240 |
| Cytarabine 100 mg/ml (100,000 ppm) | >240 |
| Cytovene 10 mg/ml (10,000 ppm) | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 |
| Daunorubicin 5 mg/ml (5,000 ppm) | >240 |
| Decitabine 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel 10.0 mg/ml (10,000 ppm) | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 |
| Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 |
| Fludarabine 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 |
| Fulvestrant 50.0 mg/ml (50,000 ppm) | >240 |
| Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | >240 |
| Idarubicin 1 mg/ml (1,000 ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 |
| Irinotecan 20.0 mg/ml (20,000 ppm) | >240 |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Melphalan 5 mg/ml (5,000 ppm) | >240 |
| Methotrexate 25 mg/ml (25,000 ppm) | >240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | >240 |
| Oxaliplatin 2.0 mg/ml (2,000 ppm) | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 |
| Paraplatin 10 mg/ml (10,000 ppm) | >240 |
| Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) | >240 |
| Pertuzumab 30 mg/ml (30,000 ppm) | >240 |
| Raltitrexed 0.5 mg/ml (500 ppm) | >240 |
| Retrovir 10.0 mg/ml (10,000 ppm) | >240 |
| Rituximab 10 mg/ml (10,000 ppm) | >240 |
| Temsirolimus 25.0 mg/ml (25,000 ppm) | >240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 69.2 min |
| Topotecan HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Trastuzumab 21.0 mg/ml (21,000 ppm) | >240 |
| Trisonex 1 mg/ml (1,000 ppm) | >240 |
| Vinblastine 1 mg/ml (1,000 ppm) | >240 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 |
| Vinorelbine 10 mg/ml (10,000 ppm) | >240 |
| Zoledronic Acid 0.8 mg/ml (800 ppm) | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white cross behind it. The background is a solid dark blue. There is a gray bar on the right side of the image.

Northfield II 60093

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes Thiotepa (10.0 mg/ml) 69.2 minutes

CAUTION: Testing showed an average breakthrough time of 33.1 minutes with Carmustine and 69.2 minutes with Thiotepa.

# Indications for Use – Extended Cuff (VS711XS, VS711M, VS711M, VS711L and VS711XL)

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

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

| Chemo Drugs Tested: | Breakthrough Time (Minutes |
|---------------------------------------|----------------------------|
| Aresenic Trioxide 1 mg/ml | >240 |
| Azacitidine 25 mg/ml | >240 |
| Bendamustine 5 mg/ml | >240 |
| Bleomycin 15 mg/m | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carfilzomib 2 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 59.4 min |
| Cetuximab | >240 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine Hydrochloride 100 mg/ml | >240 |
| Cytovene 10 mg/ml | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Decitabine 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Epirubicin (Ellence) 2.0 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50.0 mg/ml | >240 |
| Fulvestrant 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25.0 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Oxaliplatin 5.0 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin (Carboplatin) 10 mg/ml | >240 |
| Pemetrexed Disodium 25.0 mg/ml | >240 |
| Pertuzumab 30 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Retrovir 10.0 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Temsirolimus 25.0 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 68.2 min |
| Topotecan HCI 1.0 mg/ml | >240 |
| Trastuzumab 21.0 mg/ml | >240 |
| Trisonex 1 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Zoledronic Acid 0.8 mg/ml | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |

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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, positioned to the left of a white, four-pointed star-like symbol. The background is a solid dark blue color. A small gray rectangle is visible in the upper right corner of the image.

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Image /page/11/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol to the right of the text. The background is a solid blue color. There is a gray bar at the top right corner of the image.

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 59.4 minutes Thiotepa (10.0 mg/ml) 68.2 minutes

CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with Thiotepa.

# Comparison of Technological Characteristics

| Device<br>Characteristic | Proposed<br>Device<br>VS311 | Predicate<br>Device | Comparison Analysis |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Medline Powder-Free Blue<br>Nitrile Examination Gloves<br>(Tested for use with<br>Chemotherapy Drugs and<br>Fentanyl)<br>Regular Cuff | Non-Sterile, Powder-Free<br>Nitrile Examination Gloves<br>(Cobalt) Tested for use with<br>chemotherapy drugs | N/A |
| 510(k) Reference | K193666 | K111248 | N/A |
| Product Owner | Medline Industries, Inc. | YTY Industry (Manjung) SDN,<br>BHD | N/A |
| Product Code | LZA, OPJ, QDO | LZA, LZC | Similar |
| | | | |
| Intended Use | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and examiner<br>These gloves were tested for<br>use with Chemotherapy drugs<br>and Fentanyl Citrate as per<br>ASTM D6978-05 (Reapproved<br>2019) Standard Practice for<br>Assessment of Medical Gloves<br>of Permeation by<br>Chemotherapy Drugs | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or fingers to prevent<br>contamination between<br>patient and examiner.<br>These glove were tested for<br>use with chemotherapy drugs. | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Blue | Blue | Same |
| Sizes | x- small, small, medium, large,<br>x-large | Medium, Large, Extra-large | Similar |
| Dimensions -<br>Length | Complies with:<br>ASTM D6319-10<br>220mm min. | Complies with:<br>ASTM D6319-10<br>220mm min. | Same |
| Dimensions -<br>Width | Complies with:<br>ASTM D6319-10<br>70mm min | Complies with:<br>ASTM D6319-10<br>70mm min | Same |
| Dimensions -<br>Thickness | Complies with:<br>ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Complies with:<br>ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Same |
| Physical<br>Properties | Complies with:<br>ASTM D6319-10 minimum:<br><br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with:<br>ASTM D6319-10 minimum:<br><br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Same |
| Freedom from<br>Holes | Complies with:<br>ASTM D6319-10 and<br>ASTM D5151-06 G-1,<br>AQL 1.5 | Complies with:<br>ASTM D6319-10 and<br>ASTM D5151-06 G-1,<br>AQL 2.5 | Same |
| Powder or<br>Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with:<br>ASTM D6319-10<br><2mg per glove | Complies with:<br>ASTM D6319-05<br><2mg per glove | Same |
| Contact Durations | Limited <24 hours | Limited <24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only<br>or<br>OTC | Over the Counter | Over the Counter | Same |
| Tested<br>Chemotherapy<br>Drugs | Aresenic Trioxide 1.0 mg/ml<br>(1,000 ppm)<br>>240 min. | | Different |
| | Azacitidine (Vidaza) 25.0 mg/ml<br>(25,000 ppm)<br>>240 min. | | Different |
| | Bendamustine 5.0 mg/ml (5,000<br>ppm)<br>>240 min. | | Different |
| | Bleomycin 15.0 mg/ml (15,000<br>ppm)<br>>240 min. | | Different |
| | Bortezomib 1.0 mg/ml<br>(1,000 ppm) | | Different |
| | | | |
| Busulfan 6.0 mg/ml<br>(6,000 ppm)<br>>240 min. | | Different | |
| Carboplatin 10mg/ml<br>10,000 ppm<br>>240 min | Carboplatin 10mg/ml<br>10,000 ppm<br>>240 min | Same | |
| Carfilzomib 2.0 mg/ml<br>(2,000 ppm)<br>>240 min. | | Different | |
| Carmustine (BCNU) 3.3 mg/ml<br>(3,300 ppm)<br>33.1 min. | Carmustine (BCNU) 3.3 mg/ml<br>(3,300 ppm)<br>1.82 min | Similar | |
| Cetuximab 2.0 mg/ml<br>(2,000 ppm)<br>>240 min | | Different | |
| Cisplatin 1.0 mg/ml<br>(1,000 ppm)<br>>240 min. | Cisplatin 1.0 mg/ml<br>(1,000 ppm)<br>>240 min. | Same | |
| Cyclophosphamide (Cytoxan)<br>20.0 mg/ml<br>(20,000 ppm)<br>>240 min. | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml<br>(20,000 ppm)<br>>240 min. | Same | |
| Cytarabine 100.0 mg/ml<br>(100,000 ppm)<br>>240 min. | | Different | |
| Cytovene 10.0 mg/ml<br>(10,000 ppm)<br>>240 min. | | Different | |
| Dacarbazine (DTIC) 10.0 mg/ml<br>(10,000 ppm)<br>>240 min. | Dacarbazine (DTIC) 10 mg/ml<br>(10,000 ppm)<br>>240 min. | Same | |
| Daunorubicin 5.0 mg/ml<br>(5,000 ppm)<br>>240 min. | | Different | |
| Decitabine 5.0 mg/ml<br>(5,000 ppm)<br>>240 min. | | Different | |
| Docetaxel 10.0 mg/ml<br>(10,000 ppm)<br>>240 min. | | Different | |
| Doxorubicin Hydrochloride 2.0<br>mg/ml<br>(2,000 ppm)<br>>240 min. * | Doxorubicin Hydrochloride<br>2.0 mg/ml<br>(2,000 ppm)<br>>240 min | Same | |
| Epirubicin (Ellence)<br>2.0 mg/ml<br>(2,000 ppm)<br>>240 min. | | Different | |
| Etoposide (Toposar)<br>20.0 mg/ml<br>(20,000 ppm)<br>>240 min. * | Etoposide (Toposar)<br>20.0 mg/ml<br>(20,000 ppm)<br>>240 min. | Same | |
| Fludarabine 25.0 mg/ml<br>(25,000 ppm)<br>>240 min. | | Different | |
| Fluorouracil 50.0 mg/ml<br>(50,000 ppm)<br>>240 min. | Fluorouracil 50.0 mg/ml<br>(50,000 ppm)<br>>240 min. | Same | |
| Fulvestrant 50.0 mg/ml (50,000 ppm)<br>>240 min. | | Different | |
| Gemcitabine (Gemzar) 38.0<br>mg/ml<br>(38,000 ppm)<br>>240 min. | | Different | |
| Idarubicin 1.0 mg/ml<br>(1,000 ppm)<br>>240 min. | | Different | |
| Ifosfamide 50.0 mg/ml<br>(50,000 ppm)<br>>240 min. | Ifosfamide 50.0 mg/ml<br>(50,000 ppm)<br>>240 min. | Same | |
| Irinotecan 20.0 mg/ml<br>(20,000 ppm)<br>>240 min. | | Different | |
| Mechlorethamine HCl 1.0<br>mg/ml<br>(1,000 ppm)<br>>240 min. | | Different | |
| Melphalan 5.0 mg/ml<br>(5,000 ppm)<br>>240 min. | | Different | |
| | | | |
| Methotrexate 25.0 mg/ml<br>(25,000 ppm)<br>>240 min. * | Methotrexate 25.0 mg/ml<br>(25,000 ppm)<br>>240 min. | Same | |
| Mitomycin C 0.5 mg/ml<br>(500 ppm)<br>>240 min. | Mitomycin C 0.5 mg/ml<br>(2,000 ppm)<br>>240 min. | Same | |
| Mitoxantrone 2.0 mg/ml<br>(2,000 ppm)<br>>240 min. | Mitoxantrone 2.0 mg/ml<br>(2,000 ppm)<br>>240 min. | Same | |
| Oxaliplatin 2.0 mg/ml<br>(2,000 ppm)<br>>240 min. | | Different | |
| Paclitaxel (Taxol) 6.0 mg/ml<br>(6,000 ppm)<br>>240 min. | Paclitaxel (Taxol) 6.0 mg/ml<br>(6,000 ppm)<br>>240 min. | Same | |
| Paraplatin 10.0 mg/ml<br>(10,000 ppm)<br>>240 min. | | Different…