Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for

K200671 · Ansell Healthcare Products, LLC · LZA · Jun 19, 2020 · General Hospital

Device Facts

• Record ID: K200671
• Device Name: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
• Applicant: Ansell Healthcare Products, LLC
• Product Code: LZA · General Hospital
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile butadiene rubber examination gloves; available in blue, green, and pink. Features beaded cuff, straight fingers, and finger-textured surface; coated with polyacrylic polymer for donning and infused with aloe and chamomile. Used by healthcare professionals in clinical settings to prevent cross-contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05; pink variant also tested against Fentanyl Citrate. Output is a physical barrier; healthcare providers use gloves during patient examinations and handling of hazardous drugs. Benefits include protection against patient-to-examiner contamination and chemical permeation during drug handling.

Clinical Evidence

Bench testing only. No clinical data required. Performance validated via ASTM D6319-10 (dimensions, physical properties, freedom from holes, powder residual), ASTM D6978-05 (chemotherapy drug permeation), and ISO 10993 series (cytotoxicity, skin irritation, sensitization, acute systemic toxicity).

Technological Characteristics

Material: Nitrile butadiene rubber. Coating: Polyacrylic polymer (donning), aloe and chamomile. 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, ISO 10993-10, ISO 10993-11. Non-sterile, single-use.

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 specific chemotherapy drugs and (for the pink variant) Fentanyl Citrate. Contraindicated for use with Carmustine.

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

• Micro-Touch NitraTex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) (K082457)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 19, 2020

Ansell Healthcare Products LLC Donald Cronk Associate Director, Regulatory Affairs - Americas 2301 Robb Drive Reno, Nevada 89523

Re: K200671

Trade/Device Name: Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Green Colored Tested for Use with Chemotherapy Drugs Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl CitrateRegulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO (for pink glove only) Dated: May 21, 2020 Received: May 22, 2020

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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,

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) K200671

#### Device Name

Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs

#### 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|----------------------------------------|-----------------------------------------------|
| Carmustine (BCNU) - 3.3 mg/ml | 17.4 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) 2.0 mg/ml | >240 |
| Etoposide (Toposar) - 20.0 mg/ml | >240 |
| Fluorouracil (Adrucil) - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) - 6.0 mg/ml | >240 |
| Thiotepa (THT) - 10.0 mg/ml | 67.1 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmusine (BCNU) : 17.4 minutes and Thiotepa: 67.1 minutes. Warning: Do not use with Carmustine.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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# Indications for Use

### 510(k) Number (if known) K200671

#### Device Name

Microllex® Nitrile Patient Examination Gloves with Aloe and Chamonile Green Colored Tested for Use with Chemotherapy Drugs

#### 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Tested chemotherapy drugs are as follows: | |
|-------------------------------------------|-----------------------------------------------|
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
| Carmustine (BCNU) - 3.3 mg/ml | 27.9 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) 2.0 mg/ml | >240 |
| Etoposide (Toposar) - 20.0 mg/ml | >240 |
| Fluorouracil (Adrucil) - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) - 6.0 mg/ml | >240 |
| Thiotepa (THT) - 10.0 mg/ml | 48.6 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 27.9 minutes and Thiotepa: 48.6 minutes. Warning: Do not use with Carmustine.

| 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) | <div> <span> </span> </div> |

## 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."

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# Indications for Use

510(k) Number (if known) K200671

#### Device Name

Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Druss 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 of Medical Gloves to Permeation by Chemotherapy Drugs.

| Tested chemotherapy drugs are as follows: | |
|-------------------------------------------|-----------------------------------------------|
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
| Carmustine (BCNU) - 3.3 mg/ml | 23.4 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) 2.0 mg/ml | >240 |
| Etoposide (Toposar) - 20.0 mg/ml | >240 |
| Fentanyl Citrate Injection - 100 mcg/2mL | >240 |
| Fluorouracil (Adrucil) - 50.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) - 6.0 mg/ml | >240 |
| Thiotepa (THT) - 10.0 mg/ml | 64.9 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation (BCNU): 23.4 minutes and Thiotepa: 64.9 minutes. Warning: Do not use with Carmustine.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

## 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."

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# 510K Summary

## 510(k) Number:

K200671

# Submitter:

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

# Contact Person:

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

## Date Prepared:

6/19/2020

## Name of the Device:

| Trade Names: | 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 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Micro-Touch NitraTex Sterile Nitrile Powder-Free Blue Examination<br>Gloves (Chemotherapy Use) |
| 510(k) Number: | K082457 |
| Device Class: | Class I |
| Product Code: | LZA (Nitrile) |
| Device Name: | Patient Examination Glove (21 CFR 880.6250) |

## Device Description:

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

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Characteristic:

- Ambidextrous with beaded cuff and straight fingers
- Finger-textured, ●
- Blue, green or pink colored
- Containing aloe and chamomile.
- Five (5) sizes – extra-small, small, medium, large, and extra-large.
- . Tested against chemotherapy drugs and fentanyl citrate (pink only).

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

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

# Indications for Use Statements:

Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink 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.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy Drug & Concentration | Average Breakthrough Detection Time (Min) |
|------------------------------------------|-------------------------------------------|
| Carmustine (BCNU) – 3.3 mg/ml | 23.4 |
| Cyclophosphamide – 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) – 2.0 mg/ml | >240 |
| Etoposide (Toposar) – 20.0 mg/ml | >240 |
| Fentanyl Citrate Injection – 100 mcg/2mL | >240 |
| Fluorouracil (Adrucil) – 50.0 mg/ml | >240 |
| Methotrexate – 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) – 6.0 mg/ml | >240 |
| Thiotepa (THT) – 10.0 mg/ml | 64.9 |
| Vincristine Sulfate – 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 23.4 minutes and Thiotepa: 64.9 minutes. Warning: Do not use with Carmustine.

Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs

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 as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.

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Tested chemotherapy drugs are as follows:

| Test Chemotherapy Drug & Concentration | Average Breakthrough Detection Time (Min) |
|------------------------------------------|-------------------------------------------|
| Carmustine (BCNU) – 3.3 mg/ml | 17.4 |
| Cyclophosphamide – 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) – 2.0 mg/ml | >240 |
| Etoposide (Toposar) – 20.0 mg/ml | >240 |
| Fluorouracil (Adrucil) – 50.0 mg/ml | >240 |
| Methotrexate – 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) – 6.0 mg/ml | >240 |
| Thiotepa (THT) – 10.0 mg/ml | 67.1 |
| Vincristine Sulfate – 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 17.4 minutes and Thiotepa: 67.1 minutes. Warning: Do not use with Carmustine.

Microflex® Nitrile Patient Examination Glove with Aloe and Chamomile Green Colored Tested for Use with Chemotherapy Drugs

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 as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy Drug & Concentration | Average Breakthrough Detection Time (Min) |
|------------------------------------------|-------------------------------------------|
| Carmustine (BCNU) – 3.3 mg/ml | 27.9 |
| Cyclophosphamide – 20.0 mg/ml | >240 |
| Doxorubicin HCl (Adriamycin) – 2.0 mg/ml | >240 |
| Etoposide (Toposar) – 20.0 mg/ml | >240 |
| Fluorouracil (Adrucil) – 50.0 mg/ml | >240 |
| Methotrexate – 25.0 mg/ml | >240 |
| Paclitaxel (Taxol) – 6.0 mg/ml | >240 |
| Thiotepa (THT) – 10.0 mg/ml | 48.6 |
| Vincristine Sulfate – 1.0 mg/ml | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 27.9 minutes and Thiotepa: 48.6 minutes. Warning: Do not use with Carmustine.

# Technological Characteristics:

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

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| 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 - XS | 70 ± 10 | 75 ± 5 |
| Size - S | 80 ± 10 | 85 ± 5 |
| Size - M | 95 ± 10 | 95 ± 5 |
| Size - L | 110± 10 | 105 ± 5 |
| Size - XL | 120 ± 10 | 115 ± 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 | Meets applicable requirement for powder free;<br>≤ 2 mg per glove |
| | ASTM D6124-06 | |
| Biocompatibility: | | |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, undiluted, 1:2, 1:4, 1:8, 1:16 dilution was cytotoxic., 1:32 and 1:64 are not cytotoxic |
| ISO Skin Irritation Study | ISO10993-10:2010 | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence of systemic toxicity |

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# Substantial Equivalence:

| | Predicate Device | Proposed Subject Device | Substantial<br>Equivalence to<br>Predicate |
|---------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Trade name | Micro-Touch NitraTex Sterile<br>Nitrile Powder-Free Blue<br>Examination Gloves<br>(Chemotherapy Use) | Microflex® Nitrile Patient<br>Examination Gloves with Aloe<br>and Chamomile Blue Colored<br>Tested for Use with<br>Chemotherapy Drugs<br>Microflex® Nitrile Patient<br>Examination Gloves with Aloe<br>and Chamomile Green Colored<br>Tested for Use with<br>Chemotherapy Drugs<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 | Not applicable |
| 510k Number | K082457 | K200671 | Not Applicable |
| Product Owner | Ansell Healthcare | Ansell Healthcare | Ansell Healthcare |
| Product Code | LZA | LZA, LZC, QDO | Similar |

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| 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 | The 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 | 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 | Yes |
| Material<br>Composition | Synthetic nitrile rubber | Synthetic nitrile rubber | Yes |
| Coating | Polyacrylic polymer inner coating to aid donning | Polyacrylic polymer inner coating to aid donning | Yes |
| Aloe and<br>Chamomile | N/A | Aloe and Chamomile coated on the donning surface | 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, Blue, and Pink | 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 |

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| e. Sterility | Non-sterile | Non-sterile | Yes | | |
|-----------------------|----------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------|------|--|
| Biocompatibility | Passes Primary Skin Irritation Test<br>and Dermal Sensitization Test | | Passes Primary Skin Irritation<br>Test and Dermal Sensitization<br>Test and Acute Systemic Toxicity<br>Test | Yes | |
| Chemotherapy<br>Claim | Predicate Device | Pink Device | As Noted (Fentanyl<br>Citrate) | | |
| | Carmustine (BCNU) | 32.1 | Carmustine (BCNU) | 23.4 | |
| | Cyclophosphamide | >240 | Cyclophosphamide | >240 | |
| | Doxorubicin HCl<br>(Adriamycin) | >240 | Doxorubicin HCl<br>(Adriamycin) | >240 | |
| | Etoposide (Toposar) | >240 | Etoposide (Toposar) | >240 | |
| | Fluorouracil (Adrucil) | >240 | Fluorouracil (Adrucil) | >240 | |
| | Methotrexate | >240 | Methotrexate | >240 | |
| | Paclitaxel (Taxol) | >240 | Paclitaxel (Taxol) | >240 | |
| | Thiotepa (THT) | 140.7 | Thiotepa (THT) | 64.9 | |
| | Vincristine Sulfate | >240 | Vincristine Sulfate | >240 | |
| | | | Fentanyl Citrate<br>Injection | >240 | |
| Chemotherapy<br>Claim | Predicate Device | Blue Device | Yes | | |
| | Carmustine (BCNU) | 32.1 | Carmustine (BCNU) | 17.4 | |
| | Cyclophosphamide | >240 | Cyclophosphamide | >240 | |
| | Doxorubicin HCl<br>(Adriamycin) | >240 | Doxorubicin HCl<br>(Adriamycin) | >240 | |
| | Etoposide (Toposar) | >240 | Etoposide (Toposar) | >240 | |
| | Fluorouracil (Adrucil) | >240 | Fluorouracil (Adrucil) | >240 | |
| | Methotrexate | >240 | Methotrexate | >240 | |
| | Paclitaxel (Taxol) | >240 | Paclitaxel (Taxol) | >240 | |
| | Thiotepa (THT) | 140.7 | Thiotepa (THT) | 67.1 | |
| | Vincristine Sulfate | >240 | Vincristine Sulfate | >240 | |

{12}------------------------------------------------

| Chemotherapy<br>Claim | Predicate Device | Green Device | Yes |
|-----------------------|--------------------------------------|--------------------------------------|-----|
| | Carmustine (BCNU) 32.1 | Carmustine (BCNU) 27.9 | |
| | Cyclophosphamide >240 | Cyclophosphamide >240 | |
| | Doxorubicin HCl<br>(Adriamycin) >240 | Doxorubicin HCl<br>(Adriamycin) >240 | |
| | Etoposide (Toposar) >240 | Etoposide (Toposar) >240 | |
| | Fluorouracil (Adrucil) >240 | Fluorouracil (Adrucil) >240 | |
| | Methotrexate >240 | Methotrexate >240 | |
| | Paclitaxel (Taxol) >240 | Paclitaxel (Taxol) >240 | |
| | Thiotepa (THT) 140.7 | Thiotepa (THT) 48.6 | |
| | Vincristine Sulfate >240 | Vincristine Sulfate >240 | |

The subject device meets the applicable requirements for patient examination gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D6319, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity, in accord with the ISO 10993 series of standards.

A clinical study was not required for the subject or predicate devices.

# Conclusion

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