Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a patient examination glove, and the description focuses on material properties, testing against chemicals, and standard compliance, with no mention of AI or ML.

Therapeutic

No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.

Diagnostic

No

The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function such as identifying diseases or conditions.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of nitrile butadiene rubber, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description details the physical characteristics and materials of a glove. It mentions testing for permeation by chemotherapy drugs and fentanyl citrate, which relates to the protective function of the glove, not to diagnostic testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, freedom from holes, etc.) and biological reactivity (sensitization, toxicity), which are relevant to a medical device worn on the skin, not an IVD.

In summary, the device is a medical device intended for barrier protection, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
For Microflex® Nitrile Patient Examination Gloves Blue Colored: Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes. Warning: Do not use with Carmustine.
For Microflex® Nitrile Patient Examination Gloves Green Colored: Please note that the following drug has an extremely low permeation time: Carmustine: 49.6 minutes. Warning: Do not use with Carmustine.
For Microflex® Nitrile Patient Examination Gloves Black Colored: Please note that the following drug has an extremely low permeation time: Carmustine: 27.6 minutes. Warning: Do not use with Carmustine.

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, QDO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner / Medical purposes

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject devices meet 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 devices pass biological reactivity testing for dermal sensitization and acute systemic toxicity, in accordance with the ISO 10993 series of standards.
The gloves were 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.
Key results for breakthrough detection time (minutes) for specified drugs:
Blue Colored Gloves: 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.
Green Colored Gloves: 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.
Black Colored Gloves: 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.
A clinical study was not required for the subject or predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. Information provided in the form of breakthrough detection time for chemical permeation.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K200671

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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 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."

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 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."

5

510K Summary

Submitter:

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

Contact Person(s):

Don Cronk Associate Director, Regulatory Affairs Phone: (775) 470-7106 Email: don.cronk@ansell.com

Jacob Ramirez Senior Coordinator, Regulatory Affairs Phone: (775) 624-8118 Email: jacob.ramirez@ansell.com

Date Prepared:

5/3/2021

Name of the Device:

| Trade Names: | 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 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
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
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.

7

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
CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION
TIME
(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
CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION
TIME
(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
CONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTION
TIME
(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/
FDA Guidance | Result Summary |
|-----------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Physical Characteristics: | | |
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for
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
strength and ultimate elongation before and
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
ASTM D5151-06 | Meets or exceeds ASTM D6319-10 and ASTM
D5151-06 requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10
ASTM D6124-06 | Meets applicable requirement for powder free;
≤ 2 mg per glove |
| 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 |

11

12

Substantial Equivalence:

| | Predicate Device | Proposed Subject Device | Substantial
Equivalence to
Predicate |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Trade 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 Citrate | 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

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14

| Chemotherapy
Claim | Microflex® Nitrile Patient Examination
Gloves with Aloe and Chamomile Blue
Colored Tested for Use with
Chemotherapy Drugs | Microflex® Nitrile Patient Examination
Gloves Blue Colored Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate | As Noted
(Fentanyl Citrate) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | The Nitrile Patient Examination Glove
with Aloe and Chamomile Blue Colored is
intended to be worn by operating room
personnel to protect a surgical wound
from contamination. 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.
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.

Tested chemotherapy drugs are as
follows: | 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.

Tested chemotherapy drugs are as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Test
Chemotherapy
Drug and
Concentration Average
Minimum
Breakthrough
Detection Time
(Minutes) Carmustine (3.3
mg/ml) 17.4 Cyclophosphamide
(20.0 mg/ml) >240 Doxorubicin HCl
(2.0 mg/ml) >240 Etoposide (20.0
mg/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) 67.1 Vincristine Sulfate
(1.0 mg/ml) >240 | | | | | | | | | | | | | | | | | | | | | Test
Chemotherapy
Drug and
Concentration Average
Minimum
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 | | | | | | | | | | | | | | | | | | | | | | | |
| Chemotherapy
Claim | Microflex® Nitrile Patient Examination
Gloves with Aloe and Chamomile Green
Colored Tested for Use with
Chemotherapy Drugs | Microflex® Nitrile Patient Examination
Gloves Green Colored Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate | As Noted
(Fentanyl Citrate) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | The Nitrile Patient Examination Glove
with Aloe and Chamomile Green Colored
is intended to be worn by operating room
personnel to protect a surgical wound
from contamination. 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.
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. | 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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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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)
Paclitaxel (6.0		Fentanyl Citrate
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)


	Microflex® Nitrile Patient Examination		Microflex® Nitrile Patient Examination
Chemotherapy	Gloves with Aloe and Chamomile Pink		Gloves Black Colored Tested for Use with		Yes
Claim	Colored Tested for Use with		Chemotherapy Drugs and Fentanyl Citrate
	Chemotherapy Drugs and Fentanyl Citrate
			A powder-free patient examination glove is
	The Nitrile Patient Examination Glove		a disposable device intended for medical
	with Aloe and Chamomile Pink Colored is		purposes that is worn on the examiner's
	intended to be worn by operating room		hand to prevent contamination between
	personnel to protect a surgical wound
from contamination. The glove was tested		patient and examiner. The glove was tested
	for use with Chemotherapy Drugs and		for use with Chemotherapy Drugs and
Fentanyl Citrate as per ASTM D6978-05
	Fentanyl Citrate as per ASTM D6978-05		Standard Practice for Assessment for
	Standard Practice for Assessment for		Medical Gloves to Permeation by
	Medical Gloves to Permeation by		Chemotherapy Drugs. Please note that the
	Chemotherapy Drugs. Please note that		following drug has an extremely low
	the following drugs have extremely low		permeation time: Carmustine: 27.6
	permeation times: Carmustine (BCNU):		minutes. Warning: Do not use with
	23.4 minutes and Thiotepa: 64.9 minutes.		Carmustine.
	Warning: Do not use with Carmustine.
	Tested chemotherapy drugs are as		Tested chemotherapy drugs are as follows:
	follows:
			Test
Chemotherapy	Minimum
Breakthrough
	Test	Average	Drug and	Detection Time
	Chemotherapy	Minimum	Concentration
	Drug and	Breakthrough
	Concentration	Detection Time	Carmustine (3.3	27.6
		(Minutes)	mg/ml)
	Carmustine (3.3	23.4	Cyclophosphamide	>240
	mg/ml)		(20.0 mg/ml)
	Cyclophosphamide
(20.0 mg/ml)	>240	Doxorubicin HCl
(2.0 mg/ml)	>240

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| 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)	64.9
Vincristine Sulfate
(1.0 mg/ml)	>240

The subject devices meet 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 devices pass biological reactivity testing for dermal sensitization and acute systemic toxicity, in accordance 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.