Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K210401 · Ansell Healthcare Products, LLC · LZA · Jun 13, 2021 · General Hospital

Device Facts

• Record ID: K210401
• Device Name: Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Ansell Healthcare Products, LLC
• Product Code: LZA · General Hospital
• Decision Date: Jun 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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

Disposable, non-sterile, powder-free nitrile butadiene rubber examination gloves; ambidextrous, beaded cuff, finger-textured. Available in blue, green, or black. Polyacrylic polymer inner coating facilitates donning. Used in clinical settings by healthcare personnel to prevent cross-contamination between patient and examiner. Tested per ASTM D6978-05 for permeation resistance against specific chemotherapy drugs and fentanyl citrate. Protects examiner and patient from contamination; provides barrier protection during handling of hazardous drugs. High ozone levels degrade material; must be protected from ozone.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including physical dimensions (ASTM D6319-10), tensile strength/elongation (ASTM D6319-10), freedom from holes (ASTM D5151-06), powder residual (ASTM D6124-06), and biocompatibility (ISO 10993-5, -10, -11). Permeation testing performed per ASTM D6978-05.

Technological Characteristics

Material: Nitrile butadiene rubber. Coating: Polyacrylic polymer. Design: Ambidextrous, beaded cuff, finger-textured. Standards: ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (holes), ASTM D6124-06 (powder), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity). Non-sterile.

Indications for Use

Indicated for use as a disposable, powder-free 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

• Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile (K200671)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

June 13, 2021

Ansell Healthcare Products LLC Donald Cronk Associate Director 2301 Robb Drive Reno, Nevada 89523

# Re: K210401

Trade/Device Name: Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: February 8, 2021 Received: February 10, 2021

Dear Donald Cronk:

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

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Ryan Ortega 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)

#### K210401

#### Device Name

Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentary1 Citrate

Indications for Use (Describe)

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentany) Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes. Warning: Do not use with Carmustine.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|-------------------------------------------|-----------------------------------------------|
| Carmustine - 3.3 mg/ml | 47.9 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Doxorubicin HCl - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fentanyl Citrate Injection - 100 mcg/2 ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | >240 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

## 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."

{3}------------------------------------------------

# Indications for Use

510{k} Number (if known)

#### K210401

#### Device Name

Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentary| Citrate

#### Indications for Use (Describe)

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentany) Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 49.6 minutes. Warning: Do not use with Carmustine.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|-------------------------------------------|-----------------------------------------------|
| Carmustine - 3.3 mg/ml | 49.6 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Doxorubicin HCl - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fentanyl Citrate Injection - 100 mcg/2 ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | >240 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

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

J Prescription Use (Part 21 CFR 801 Subpart D)

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 [e-mail]

"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."

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K210401

Device Name

Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time; Carmustine: 27.6 minutes. Warning: Do not use with Carmustine.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|-------------------------------------------|-----------------------------------------------|
| Carmustine - 3.3 mg/ml | 27.6 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Doxorubicin HCl - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fentanyl Citrate Injection - 100 mcg/2 ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | >240 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

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

Prescription Use (Part 21 CFR 801 Subpart D)

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 [e-mail]

"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."

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

# 510K Summary

# Submitter:

Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523

## Contact Person(s):

Don Cronk Associate Director, Regulatory Affairs Phone: [phone] Email: [e-mail]

Jacob Ramirez Senior Coordinator, Regulatory Affairs Phone: [phone] Email: [e-mail]

## Date Prepared:

5/3/2021

# Name of the Device:

| Trade Names: | Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for<br>Use with Chemotherapy Drugs and Fentanyl Citrate<br>Microflex® Nitrile Patient Examination Gloves Green Colored Tested for<br>Use with Chemotherapy Drugs and Fentanyl Citrate<br>Microflex® Nitrile Patient Examination Gloves Black Colored Tested for<br>Use with Chemotherapy Drugs and Fentanyl Citrate |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove |
| Classification Regulation: | 21 CFR 880.6250 |
| Device Class: | I |
| Product Code: | LZA, LZC, QDO |
| Classification Panel: | Non-powdered patient examination glove |

## Legally Marketed Predicate Device:

| Company: | Ansell Healthcare Products LLC |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile<br>Blue Colored Tested for Use with Chemotherapy Drugs<br>Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile<br>Green Colored Tested for Use with Chemotherapy Drugs<br>Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile<br>Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl<br>Citrate |
| 510(k) Number: | K200671 |
| Device Class: | Class I |
| Product Code: | LZA, LZC, QDO |
| Device Name: | Patient Examination Glove (21 CFR 880.6250) |

{6}------------------------------------------------

# Device Description:

Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves are made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the gloves to make donning easy.

Characteristics:

- . Ambidextrous with beaded cuff and straight fingers
- . Finger-textured
- Blue, green, or black colored .
- . Four (4) sizes - small, medium, large, and extra-large
- . Tested against chemotherapy drugs and fentanyl citrate

High levels of ozone will degrade rubber material of the gloves; therefore, the gloves should be protected from ozone in particular.

The gloves are designed to meet the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

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## Indications for Use Statements:

Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes. Warning: Do not use with Carmustine.

| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION<br>TIME<br>(Sample 1,2,3) (Minutes) |
|---------------------------------------------|----------------------------------------------------------------------------|
| Carmustine (3.3 mg/ml) | 47.9 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2 ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thieptepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Tested chemotherapy drugs are as follows:

{8}------------------------------------------------

Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 49.6 minutes. Warning: Do not use with Carmustine.

| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION<br>TIME<br>(Sample 1,2,3) (Minutes) |
|---------------------------------------------|----------------------------------------------------------------------------|
| Carmustine (3.3 mg/ml) | 49.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2 ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thieptepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Tested chemotherapy drugs are as follows:

{9}------------------------------------------------

Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 27.6 minutes. Warning: Do not use with Carmustine.

| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION<br>TIME<br>(Sample 1,2,3) (Minutes) |
|---------------------------------------------|----------------------------------------------------------------------------|
| Carmustine (3.3 mg/ml) | 27.6 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2 ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thieptepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Tested chemotherapy drugs are as follows:

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

# Technological Characteristics:

Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate have the following technological characteristics as compared to ASTM or equivalent standards:

| Characteristics | Standard/Test/<br>FDA Guidance | Result Summary |
|-----------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Physical Characteristics: | | |
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for<br>length, width and thickness |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (mm) | | |
| Size - S | $80 \pm 10$ | $85 \pm 5$ |
| Size - M | $95 \pm 10$ | $95 \pm 5$ |
| Size - L | $110\pm 10$ | $105 \pm 5$ |
| Size - XL | $120 \pm 10$ | $115 \pm 5$ |
| Thickness (mm) - single-wall | | |
| Finger | minimum 0.05 | Finger - min 0.09 |
| Palm | minimum 0.05 | Palm - min 0.06 |
| Cuff | - | Cuff - min 0.05 |
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for tensile<br>strength and ultimate elongation before and<br>after accelerated aging: |
| Tensile Strength | | |
| Before Aging | minimum 14 MPa | minimum 16 MPa |
| After Aging | minimum 14 MPa | minimum 14 MPa |
| Ultimate Elongation | | |
| Before Aging | minimum 500% | minimum 500% |
| After Aging | minimum 400% | minimum 400% |
| Freedom from holes | ASTM D6319-10<br>ASTM D5151-06 | Meets or exceeds ASTM D6319-10 and ASTM<br>D5151-06 requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10<br>ASTM D6124-06 | Meets applicable requirement for powder free;<br>≤ 2 mg per glove |
| Biocompatibility: | | |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, undiluted,<br>1:2, 1:4, 1:8, 1:16 dilution was cytotoxic., 1:32<br>and 1:64 are not cytotoxic |
| ISO Skin Irritation Study | ISO10993-10:2010 | Under the conditions of the study, not an<br>irritant |
| ISO Maximization<br>Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not a<br>sensitizer |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence<br>of systemic toxicity |

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

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# Substantial Equivalence:

| | Predicate Device | Proposed Subject Device | Substantial<br>Equivalence to<br>Predicate |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Trade name | Microflex® Nitrile Patient<br>Examination Gloves with Aloe<br>and Chamomile Blue Colored<br>Tested for Use with<br>Chemotherapy Drugs<br><br>Microflex® Nitrile Patient<br>Examination Gloves with Aloe<br>and Chamomile Green Colored<br>Tested for Use with<br>Chemotherapy Drugs<br><br>Microflex® Nitrile Patient<br>Examination Gloves with Aloe<br>and Chamomile Pink Colored<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Microflex® Nitrile Patient<br>Examination Gloves Blue Colored<br>Tested for Use with Chemotherapy<br>Drugs and Fentanyl Citrate<br><br>Microflex® Nitrile Patient<br>Examination Gloves Green Colored<br>Tested for Use with Chemotherapy<br>Drugs and Fentanyl Citrate<br><br>Microflex® Nitrile Patient<br>Examination Gloves Black Colored<br>Tested for Use with Chemotherapy<br>Drugs and Fentanyl Citrate | Not applicable |
| 510k Number | K200671 | K210401 | Not Applicable |
| Product Owner | Ansell Healthcare | Ansell Healthcare | Yes |
| Product Code | LZA, LZC, QDO | LZA, LZC, QDO | Yes |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Yes |
| Regulatory Class | I | I | Yes |
| Regulation Name | Patient Examination Glove | Patient Examination Glove | Yes |
| Indications for use | A powder-free patient<br>examination glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner | A powder-free patient<br>examination glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner | Yes |
| Material<br>Composition | Synthetic nitrile rubber | Synthetic nitrile rubber | Yes |
| Coating | Polyacrylic polymer inner coating<br>to aid donning | Polyacrylic polymer inner coating<br>to aid donning | Yes |
| | | | |
| Aloe and<br>Chamomile | Aloe and Chamomile coated on<br>the donning surface | N/A | As noted |
| Design | Non-sterile | Non-sterile | Yes |
| | Single use | Single use | Yes |
| | Powder-free | Powder-free | Yes |
| | Ambidextrous | Ambidextrous | Yes |
| | Beaded cuff | Beaded cuff | Yes |
| Color | Blue, Green, and Pink | Blue, Green, and Black | As noted |
| Performance | Meets ASTM D6319-10<br>requirements | Meets ASTM D6319-10<br>requirements | Yes |
| a. Dimensions | | | |
| b. Physical<br>Properties | Meets ASTM D6319-10<br>requirements | Meets ASTM D6319-10<br>requirements | Yes |
| c. Freedom from<br>holes | Meets ASTM D6319-10<br>requirements of GI, AQL 2.5 | Meets ASTM D6319-10<br>requirements of GI, AQL 2.5 | Yes |
| d. Powder Residual | Meets ASTM D6319-10<br>requirements; Not more than<br>2.0mg/glove | Meets ASTM D6319-10<br>requirements; Not more than<br>2.0mg/glove | Yes |
| e. Sterility | Non-sterile | Non-sterile | Yes |
| Biocompatibility | Passes Primary Skin Irritation Test<br>and Dermal Sensitization Test<br>and Acute Systemic Toxicity Test | Passes Primary Skin Irritation Test<br>and Dermal Sensitization Test and<br>Acute Systemic Toxicity Test | Yes |

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

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| Chemotherapy<br>Claim | Microflex® Nitrile Patient Examination<br>Gloves with Aloe and Chamomile Blue<br>Colored Tested for Use with<br>Chemotherapy Drugs | Microflex® Nitrile Patient Examination<br>Gloves Blue Colored Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate | As Noted<br>(Fentanyl Citrate) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | The Nitrile Patient Examination Glove<br>with Aloe and Chamomile Blue Colored is<br>intended to be worn by operating room<br>personnel to protect a surgical wound<br>from contamination. The glove was tested<br>for use with Chemotherapy Drugs as per<br>ASTM D6978-05 Standard Practice for<br>Assessment for Medical Gloves to<br>Permeation by Chemotherapy Drugs.<br>Please note that the following drugs have<br>extremely low permeation times:<br>Carmustine (BCNU): 17.4 minutes and<br>Thiotepa: 67.1 minutes. Warning: Do not<br>use with Carmustine.<br><br>Tested chemotherapy drugs are as<br>follows: | A powder-free patient examination glove is<br>a disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand to prevent contamination between<br>patient and examiner. The glove was tested<br>for use with Chemotherapy Drugs and<br>Fentanyl Citrate as per ASTM D6978-05<br>Standard Practice for Assessment for<br>Medical Gloves to Permeation by<br>Chemotherapy Drugs. Please note that the<br>following drug has an extremely low<br>permeation time: Carmustine: 47.9<br>minutes. Warning; Do not use with<br>Carmustine.<br><br>Tested chemotherapy drugs are as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Test<br>Chemotherapy<br>Drug and<br>Concentration Average<br>Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) Carmustine (3.3<br>mg/ml) 17.4 Cyclophosphamide<br>(20.0 mg/ml) >240 Doxorubicin HCl<br>(2.0 mg/ml) >240 Etoposide (20.0<br>mg/ml) >240 Fluorouracil (50.0<br>mg/ml) >240 Methotrexate<br>(25.0 mg/ml) >240 Paclitaxel (6.0<br>mg/ml) >240 Thiotepa (10.0<br>mg/ml) 67.1 Vincristine Sulfate<br>(1.0 mg/ml) >240 | | | | | | | | | | | | | | | | | | | | | Test<br>Chemotherapy<br>Drug and<br>Concentration Average<br>Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) Carmustine (3.3<br>mg/ml) 47.9 Cyclophosphamide<br>(20.0 mg/ml) >240 Doxorubicin HCl<br>(2.0 mg/ml) >240 Etoposide (20.0<br>mg/ml) >240 Fentanyl Citrate<br>Injection (100<br>mcg/2 ml) >240 Fluorouracil (50.0<br>mg/ml) >240 Methotrexate<br>(25.0 mg/ml) >240 Paclitaxel (6.0<br>mg/ml) >240 Thiotepa (10.0<br>mg/ml) >240 Vincristine Sulfate<br>(1.0 mg/ml) >240 | | | | | | | | | | | | | | | | | | | | | | | |
| Chemotherapy<br>Claim | Microflex® Nitrile Patient Examination<br>Gloves with Aloe and Chamomile Green<br>Colored Tested for Use with<br>Chemotherapy Drugs | Microflex® Nitrile Patient Examination<br>Gloves Green Colored Tested for Use with<br>Chemotherapy Drugs and Fentanyl Citrate | As Noted<br>(Fentanyl Citrate) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | The Nitrile Patient Examination Glove<br>with Aloe and Chamomile Green Colored<br>is intended to be worn by operating room<br>personnel to protect a surgical wound<br>from contamination. The glove was tested<br>for use with Chemotherapy Drugs as per<br>ASTM D6978-05 Standard Practice for<br>Assessment for Medical Gloves to<br>Permeation by Chemotherapy Drugs.<br>Please note that the following drugs have<br>extremely low permeation times:<br>Carmustine (BCNU): 27.9 minutes and<br>Thiotepa: 48.6 minutes. Warning: Do not<br>use with Carmustine. | A powder-free patient examination glove is<br>a disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand to prevent contamination between<br>patient and examiner. The glove was tested<br>for use with Chemotherapy Drugs and<br>Fentanyl Citrate as per ASTM D6978-05<br>Standard Practice for Assessment for<br>Medical Gloves to Permeation by<br>Chemotherapy Drugs. Please note that the<br>following drug has an extremely low<br>permeation time: Carmustine: 49.6<br>minutes. Warning: Do not use with<br>Carmustine. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| | Tested chemotherapy drugs are as | | Tested chemotherapy drugs are as follows: | | |
|--------------|-----------------------------------------------------------------------------------|----------------|------------------------------------------------------------------------------|-------------------------|-----|
| | follows: | | | | |
| | | | Test | Minimum | |
| | Test | Average | Chemotherapy | Breakthrough | |
| | Chemotherapy | Minimum | Drug and | Detection Time | |
| | Drug and | Breakthrough | Concentration | | |
| | Concentration | Detection Time | | | |
| | | (Minutes) | Carmustine (3.3 | 49.6 | |
| | Carmustine (3.3 | 27.9 | mg/ml) | | |
| | mg/ml) | | Cisplatin (1.0 | >240 | |
| | Cyclophosphamide | >240 | mg/ml) | | |
| | (20.0 mg/ml) | | Cyclophosphamide | >240 | |
| | Doxorubicin HCl | >240 | (20.0 mg/ml) | | |
| | (2.0 mg/ml) | | Dacarbazine (10.0 | >240 | |
| | Etoposide (20.0 | >240 | mg/ml) | | |
| | mg/ml) | | Doxorubicin HCl | >240 | |
| | Fluorouracil (50.0 | >240 | (2.0 mg/ml) | | |
| | mg/ml) | | Etoposide (20.0 | >240 | |
| | Methotrexate | >240 | mg/ml) | | |
| | (25.0 mg/ml)<br>Paclitaxel (6.0 | | Fentanyl Citrate<br>Injection (100 | >240 | |
| | mg/ml) | >240 | mcg/2 ml) | | |
| | Thiotepa (10.0 | 48.6 | Fluorouracil (50.0 | >240 | |
| | mg/ml) | | mg/ml) | | |
| | Vincristine Sulfate | >240 | Methotrexate | >240 | |
| | (1.0 mg/ml) | | (25.0 mg/ml) | | |
| | | | Paclitaxel (6.0 | >240 | |
| | | | mg/ml) | | |
| | | | Thiotepa (10.0 | >240 | |
| | | | mg/ml) | | |
| | | | Vincristine Sulfate | >240 | |
| | | | (1.0 mg/ml)…