(123 days)
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 (Blue), 49.6 minutes (Green), 27.6 minutes (Black). Warning: Do not use with Carmustine.
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.
This is an analysis of a 510(k) Premarket Notification for medical gloves, which are considered Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against established standards rather than clinical studies involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by referring to ASTM and ISO standards for examination gloves. The reported device performance indicates that the gloves meet or exceed these standards.
Microflex Nitrile Patient Examination Gloves (Blue, Green, Black)
| Characteristics | Standard/Test/FDA Guidance | Acceptance Criteria (from Standard, implied) | Reported Device Performance |
|---|---|---|---|
| Physical Characteristics: | |||
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets ASTM D6319-10 requirements for length, width, and thickness |
| Length | Minimum 230mm | Minimum 240mm (Exceeds) | |
| Palm width (S) | 80 ± 10 mm | 85 ± 5 mm (Meets) | |
| Palm width (M) | 95 ± 10 mm | 95 ± 5 mm (Meets) | |
| Palm width (L) | 110 ± 10 mm | 105 ± 5 mm (Meets) | |
| Palm width (XL) | 120 ± 10 mm | 115 ± 5 mm (Meets) | |
| Thickness (single-wall): | |||
| Finger | minimum 0.05 mm | Finger - min 0.09 mm (Exceeds) | |
| Palm | minimum 0.05 mm | Palm - min 0.06 mm (Exceeds) | |
| Cuff | Not specified (implied to meet standard) | Cuff - min 0.05 mm | |
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements | 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 (Exceeds) | |
| Tensile Strength (After Aging) | minimum 14 MPa | minimum 14 MPa (Meets) | |
| Ultimate Elongation (Before Aging) | minimum 500% | minimum 500% (Meets) | |
| Ultimate Elongation (After Aging) | minimum 400% | minimum 400% (Meets) | |
| Freedom from holes: | ASTM D6319-10, ASTM D5151-06 | AQL 2.5 | Meets or exceeds ASTM D6319-10 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319-10, ASTM D6124-06 | ≤ 2 mg per glove | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: | |||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Undiluted, 1:2, 1:4, 1:8, 1:16 dilution was cytotoxic. 1:32 and 1:64 are not cytotoxic. (Requires clarification on acceptable dilution for "non-cytotoxic") |
| ISO Skin Irritation Study | ISO10993-10:2010 | Not an irritant | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO Acute Systemic Toxicity | ISO 10993-11:2006 | No evidence of systemic toxicity | Under the conditions of the study, no evidence of systemic toxicity |
| Chemotherapy Drug Permeation (ASTM D6978-05): | ASTM D6978-05 | No permeation within a specified time* | Varies by drug and glove color. Carmustine has low permeation (27.6 to 49.6 minutes), others generally >240 minutes. |
Note: For chemotherapy drug permeation, the acceptance criterion isn't explicitly stated as a single value (e.g., ">X minutes"), but the comparison is made against the predicate device and the standard, indicating the longer the breakthrough time, the better the performance. The warning for Carmustine suggests that its specific permeation time is deemed too low for safe use with these gloves.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the total sample size for each specific test. However, for the Chemotherapy Drug Permeation testing, it indicates "Average Minimum Breakthrough Detection Time (Sample 1,2,3) (Minutes)", implying that at least 3 samples were tested for each drug/glove combination.
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is generally understood that such testing is conducted in a laboratory setting for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission pertains to physical and chemical performance testing of medical gloves, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "ground truth" for these tests is defined by the objective measurements according to the specified ASTM and ISO standards (e.g., direct measurement of length, tensile strength testing, chemical permeation detection).
4. Adjudication Method for the Test Set
Not applicable. As there are no human interpretations or judgments required for establishing the "ground truth" (instead, it's objective measurement against standards), no adjudication method (like 2+1 or 3+1) is mentioned or relevant.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This is a Class I medical device (gloves) and not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device does not involve an algorithm. The performance studies are laboratory tests of the physical, chemical, and biological properties of the gloves.
7. Type of Ground Truth Used
The ground truth for the performance claims is based on objective measurements obtained through standardized laboratory tests according to recognized national and international standards, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions and physical properties like tensile strength, elongation, freedom from holes).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05: Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2006: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set" in the computational sense. The product development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
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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.
{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
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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 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 forUse with Chemotherapy Drugs and Fentanyl CitrateMicroflex® Nitrile Patient Examination Gloves Green Colored Tested forUse with Chemotherapy Drugs and Fentanyl CitrateMicroflex® Nitrile Patient Examination Gloves Black Colored Tested forUse 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 ChamomileBlue Colored Tested for Use with Chemotherapy DrugsMicroflex® Nitrile Patient Examination Gloves with Aloe and ChamomileGreen Colored Tested for Use with Chemotherapy DrugsMicroflex® Nitrile Patient Examination Gloves with Aloe and ChamomilePink Colored Tested for Use with Chemotherapy Drugs and FentanylCitrate |
| 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 ANDCONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTIONTIME(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 ANDCONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTIONTIME(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 ANDCONCENTRATION | AVERAGE MINIMUM BREAKTHROUGH DETECTIONTIME(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 forlength, 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 tensilestrength and ultimate elongation before andafter 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 D6319-10ASTM D5151-06 | Meets or exceeds ASTM D6319-10 and ASTMD5151-06 requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10ASTM 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., 1:32and 1:64 are not cytotoxic |
| ISO Skin Irritation Study | ISO10993-10:2010 | Under the conditions of the study, not anirritant |
| ISO MaximizationSensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not asensitizer |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidenceof systemic toxicity |
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Substantial Equivalence:
| Predicate Device | Proposed Subject Device | SubstantialEquivalence toPredicate | |
|---|---|---|---|
| Trade name | Microflex® Nitrile PatientExamination Gloves with Aloeand Chamomile Blue ColoredTested for Use withChemotherapy DrugsMicroflex® Nitrile PatientExamination Gloves with Aloeand Chamomile Green ColoredTested for Use withChemotherapy DrugsMicroflex® Nitrile PatientExamination Gloves with Aloeand Chamomile Pink ColoredTested for Use withChemotherapy Drugs andFentanyl Citrate | Microflex® Nitrile PatientExamination Gloves Blue ColoredTested for Use with ChemotherapyDrugs and Fentanyl CitrateMicroflex® Nitrile PatientExamination Gloves Green ColoredTested for Use with ChemotherapyDrugs and Fentanyl CitrateMicroflex® Nitrile PatientExamination Gloves Black ColoredTested for Use with ChemotherapyDrugs 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 patientexamination glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner | A powder-free patientexamination glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner | Yes |
| MaterialComposition | Synthetic nitrile rubber | Synthetic nitrile rubber | Yes |
| Coating | Polyacrylic polymer inner coatingto aid donning | Polyacrylic polymer inner coatingto aid donning | Yes |
| Aloe andChamomile | Aloe and Chamomile coated onthe 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 D6319-10requirements | Meets ASTM D6319-10requirements | Yes |
| a. Dimensions | |||
| b. PhysicalProperties | Meets ASTM D6319-10requirements | Meets ASTM D6319-10requirements | Yes |
| c. Freedom fromholes | Meets ASTM D6319-10requirements of GI, AQL 2.5 | Meets ASTM D6319-10requirements of GI, AQL 2.5 | Yes |
| d. Powder Residual | Meets ASTM D6319-10requirements; Not more than2.0mg/glove | Meets ASTM D6319-10requirements; Not more than2.0mg/glove | Yes |
| e. Sterility | Non-sterile | Non-sterile | Yes |
| Biocompatibility | Passes Primary Skin Irritation Testand Dermal Sensitization Testand Acute Systemic Toxicity Test | Passes Primary Skin Irritation Testand Dermal Sensitization Test andAcute Systemic Toxicity Test | Yes |
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| ChemotherapyClaim | Microflex® Nitrile Patient ExaminationGloves with Aloe and Chamomile BlueColored Tested for Use withChemotherapy Drugs | Microflex® Nitrile Patient ExaminationGloves Blue Colored Tested for Use withChemotherapy Drugs and Fentanyl Citrate | As Noted(Fentanyl Citrate) | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Nitrile Patient Examination Glovewith Aloe and Chamomile Blue Colored isintended to be worn by operating roompersonnel to protect a surgical woundfrom contamination. The glove was testedfor use with Chemotherapy Drugs as perASTM D6978-05 Standard Practice forAssessment for Medical Gloves toPermeation by Chemotherapy Drugs.Please note that the following drugs haveextremely low permeation times:Carmustine (BCNU): 17.4 minutes andThiotepa: 67.1 minutes. Warning: Do notuse with Carmustine.Tested chemotherapy drugs are asfollows: | A powder-free patient examination glove isa disposable device intended for medicalpurposes that is worn on the examiner'shand to prevent contamination betweenpatient and examiner. The glove was testedfor use with Chemotherapy Drugs andFentanyl Citrate as per ASTM D6978-05Standard Practice for Assessment forMedical Gloves to Permeation byChemotherapy Drugs. Please note that thefollowing drug has an extremely lowpermeation time: Carmustine: 47.9minutes. Warning; Do not use withCarmustine.Tested chemotherapy drugs are as follows: | ||||||||||||||||||||||||||||||||||||||||||||
| TestChemotherapyDrug andConcentration AverageMinimumBreakthroughDetection Time(Minutes) Carmustine (3.3mg/ml) 17.4 Cyclophosphamide(20.0 mg/ml) >240 Doxorubicin HCl(2.0 mg/ml) >240 Etoposide (20.0mg/ml) >240 Fluorouracil (50.0mg/ml) >240 Methotrexate(25.0 mg/ml) >240 Paclitaxel (6.0mg/ml) >240 Thiotepa (10.0mg/ml) 67.1 Vincristine Sulfate(1.0 mg/ml) >240 | TestChemotherapyDrug andConcentration AverageMinimumBreakthroughDetection Time(Minutes) Carmustine (3.3mg/ml) 47.9 Cyclophosphamide(20.0 mg/ml) >240 Doxorubicin HCl(2.0 mg/ml) >240 Etoposide (20.0mg/ml) >240 Fentanyl CitrateInjection (100mcg/2 ml) >240 Fluorouracil (50.0mg/ml) >240 Methotrexate(25.0 mg/ml) >240 Paclitaxel (6.0mg/ml) >240 Thiotepa (10.0mg/ml) >240 Vincristine Sulfate(1.0 mg/ml) >240 | ||||||||||||||||||||||||||||||||||||||||||||
| ChemotherapyClaim | Microflex® Nitrile Patient ExaminationGloves with Aloe and Chamomile GreenColored Tested for Use withChemotherapy Drugs | Microflex® Nitrile Patient ExaminationGloves Green Colored Tested for Use withChemotherapy Drugs and Fentanyl Citrate | As Noted(Fentanyl Citrate) | ||||||||||||||||||||||||||||||||||||||||||
| The Nitrile Patient Examination Glovewith Aloe and Chamomile Green Coloredis intended to be worn by operating roompersonnel to protect a surgical woundfrom contamination. The glove was testedfor use with Chemotherapy Drugs as perASTM D6978-05 Standard Practice forAssessment for Medical Gloves toPermeation by Chemotherapy Drugs.Please note that the following drugs haveextremely low permeation times:Carmustine (BCNU): 27.9 minutes andThiotepa: 48.6 minutes. Warning: Do notuse with Carmustine. | A powder-free patient examination glove isa disposable device intended for medicalpurposes that is worn on the examiner'shand to prevent contamination betweenpatient and examiner. The glove was testedfor use with Chemotherapy Drugs andFentanyl Citrate as per ASTM D6978-05Standard Practice for Assessment forMedical Gloves to Permeation byChemotherapy Drugs. Please note that thefollowing drug has an extremely lowpermeation time: Carmustine: 49.6minutes. Warning: Do not use withCarmustine. |
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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 CitrateInjection (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 woundfrom contamination. The glove was tested | patient and examiner. The glove was tested | ||||
| for use with Chemotherapy Drugs and | for use with Chemotherapy Drugs andFentanyl 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: | |||||
| TestChemotherapy | MinimumBreakthrough | ||||
| 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 CitrateInjection (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.
§ 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.