Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

K180646 · Halyard Health · LZC · Jun 27, 2018 · General Hospital

Device Facts

• Record ID: K180646
• Device Name: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
• Applicant: Halyard Health
• Product Code: LZC · General Hospital
• Decision Date: Jun 27, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes Warning: Not for Use With : Carmustine, ThioTEPA

Device Story

Disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove; packed in cardboard dispenser box. Used in clinical settings by healthcare professionals to prevent cross-contamination between patient and examiner. Provides barrier protection; tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Output is physical barrier protection; aids in maintaining sterile/clean field during patient examination and chemotherapy handling.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ASTM D5151-06 (leakage, 1.0% AQL), ASTM D6124-06 (residual powder 0.04 mg/glove), ASTM D6319-10 (tensile strength/elongation), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility testing per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity) showed no adverse responses.

Technological Characteristics

Material: Nitrile. Form: 9.5-inch, powder-free, textured fingertip, ambidextrous, non-sterile. Standards: ASTM D5151-06, ASTM D6319-10, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to specific chemotherapy drugs. Not for use with Carmustine or ThioTEPA.

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

• Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)

Reference Devices

• Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves (K081260)

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 U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Halyard Health Christine Macauley Regulatory Affairs Technical Leader 5405 Windward Parkway Alpharetta. Georgia 30004

Re: K180646

Trade/Device Name: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC. LZA Dated: Jun 11, 2018 Received: June 12, 2018

Dear Christine Macauley:

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. The general controls provisions of the Act include requirements for annual registration, Isting 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact [e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180646

#### Device Name

Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:

- Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes Warning: Not for Use With : Carmustine, ThioTEPA

| 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> |

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## 510(k) Summary-K180646

| Date Summary<br>was Prepared | June 26, 2018 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Christine L. Macauley<br>Regulatory Affairs Technical Leader<br>Halyard Health, Inc.<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>Email: [e-mail]<br>Ph: 470-448-5158 |
| Primary Contact for<br>this 510(k) Submission | Same as above |
| Device Trade Name | Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with<br>Chemotherapy Drugs |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove |
| Predicate Device | K172525<br>Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Use<br>with Chemotherapy Drugs |
| Reference Device | K081260<br>Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves |
| Subject Device Description | Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile,<br>powder-free, textured fingertip, ambidextrous, non-sterile patient<br>examination gloves that are packed in a cardboard dispenser box. Device<br>follows consensus standards:<br>• ASTM D5151-06 Standard Test Method for Detection of Holes in<br>Medical Gloves<br>• ASTM D6319-10 Standard Specification for Nitrile Examination<br>Gloves for Medical Applications<br>• ASTM D6124-06 Standard Test Method for Residual Powder on<br>Medical Gloves<br>• ASTM D6978-05 Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy Drugs<br>• ISO 10993-11:2006, Biological evaluation of medical devices - Part<br>11: Tests for Systemic Toxicity<br>• ISO 10993-10: 2010: Biological evaluation of medical devices - Part<br>10: Tests for Irritation and Skin Sensitization |

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| Indications for Use | The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with<br>Chemotherapy Drugs is a disposable device intended for medical purposes that<br>is worn on the examiner's hand to prevent contamination between patient and<br>examiner. These gloves were tested for use with the following chemotherapy<br>drugs:<br>• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes<br>• Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes<br>• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes<br>• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes<br>• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes<br>• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes<br>• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes<br>• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes<br>• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes<br>• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes<br>• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes<br>• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes<br>Warning: Not for Use With: Carmustine, ThioTEPA | | | | |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Comparison of Technological<br>Characteristics | Subject K180646<br>Lavender-colored, 9.5 inch, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, non-sterile patient<br>examination glove. | | Predicate K172525:<br>Blue-colored, 9.5 inch, nitrile, powder-<br>free, ambidextrous, non-sterile patient<br>examination glove. | | |
| Summary of comparison of<br>technological characteristics | There are no different technological characteristics of the subject device<br>compared to the predicate device. They are powder-free non-sterile nitrile exam<br>gloves tested for resistance to permeation by chemotherapydrugs. The<br>predicate device is a different color. This difference does not raise new issues of<br>safety or effectiveness of the subject device. | | | | |
| Comparison of the Subject Device with the Predicate Device | | | | | |
| | Subject Device | | Predicate Device K172525 | Remarks | |
| FDA Product<br>Code | LZC | | LZC | Same | |
| FDA<br>Classification | Class I | | Class I | Same | |
| Common Name | Medical Exam Glove | | Medical Exam Glove | Same | |

Blue Non-Sterile Powder Free

Nitrile Examination Gloves Tested

for Use with ChemotherapyDrugs

Device Trade

Name

Halyard Lavender Nitrile Powder-

Free Exam Gloves Tested for Use

with ChemotherapyDrugs

Similar but different

color

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| Indications for<br>Use | The Halyard Lavender Powder-<br>Free Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient and<br>examiner. These gloves were<br>tested for use with chemotherapy<br>drugs listed on the label. | Non-Sterile Powder Free Nitrile<br>Examination Gloves Tested for<br>Use with Chemotherapy Drugs is<br>a disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. | Same |
|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Technological<br>Characteristics | Lavender-colored, 9.5 inch, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, non-sterile patient<br>examination glove. | Technological characteristics and<br>design meet ASTM D6319-10 and<br>follow the FDA's Medical Glove<br>Guidance Manual. | Similar |
| | | Performance Data | |
| Standard | Results<br>Subject Device | Results<br>K172525 | Remarks |
| ASTM D6978-05<br>Standard<br>Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves<br>to Permeation<br>by<br>Chemotherapy<br>Drugs | No signs of breakthrough after 4<br>hours for 10 drugs.<br>Carmustine showed no signs of<br>breakthrough until 0.3 minutes and<br>Thiotepa showed no signs of<br>breakthrough until 30.9 minutes.<br>Result: Meets acceptance criteria.<br><br>• Cyclophosphamide (20.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Doxorubicin HCl (2.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Etoposide (20.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• 5-Fluorouracil (50.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Paclitaxel (Taxol) (6.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Cisplatin (1.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Dacarbazine (10.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Ifosfamide (50.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Mitoxantrone (2.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Vincristine sulfate (1.0 mg/ml) No<br>breakthrough up to 240 minutes<br><span style="color:red">• Carmustine (3.3 mg/ml) No<br/>breakthrough up to 0.3 minutes</span><br><span style="color:red">• ThioTEPA (10.0 mg.ml) No<br/>breakthrough up to 30.9 minutes</span> | Results from the Permeation data<br>for the predicate device.<br><br>• 5-Fluorouracil (50.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Etoposide (20.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Cyclophosphamide (20.0 mg/ml)<br>No breakthrough up to 240 minutes<br>• Carmustine (3.3 mg/ml) No<br>breakthrough up to 12.4 minutes<br>• ThioTEPA (10.0 mg.ml) No<br>breakthrough up to 24.4 minutes<br>• Paclitaxel (Taxol) (6.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Doxorubicin HCl (2.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Dacarbazine (10.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Cisplatin (1.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Ifosfamide (50.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Mitoxantrone (2.0 mg/ml) No<br>breakthrough up to 240 minutes<br>• Vincristine sulfate (1.0 mg/ml) No<br>breakthrough up to 240 minutes | Similar |

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| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>Gloves | Testing of the subject device<br>shows it meets the 2.5% AQL<br>requirement in the standards for<br>leakage with an actual AQL of<br>1.0%. | Testing results from the<br>Predicate device:<br>In accordance with ASTM D5151-<br>06, following ASTM D6319 AQL<br>2.5/Inspection Level G-I | Similar |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6124-06<br>Standard Test<br>Method for<br>Residual<br>Powder on<br>Medical Gloves | Residual powder on the subject<br>device is an average of 0.04<br>mg/glove within the powder-free<br>limit of < 2 mg maximum powder<br>per glove and meets the<br>acceptance criteria for powder-<br>free. | Residual Powder on the predicate<br>device is a max of 0.52 mg per<br>glove within the powder-free limit<br>of < 2 mg maximum powder per<br>glove and meets the acceptance<br>criteria for powder-free | Similar |

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| ASTM D6319-10<br>Standard<br>Specification for<br>Nitrile<br>Examination<br>Gloves for<br>Medical<br>Applications | The physical dimensions of the<br>subject device is within the limits of<br>the standard and the physical<br>properties of the subject device<br>meet the requirements for tensile<br>strength with an average before<br>aging of 30.56 MPa and after<br>aging of 37.53 MPa and elongation<br>of 593% before aging and 533%<br>after aging. | The physical dimensions of the<br>subject device is within the limits<br>of the standard and the physical<br>properties of the subject device<br>meet the requirements for tensile<br>strength with an average before<br>aging of 15 MPa and after aging<br>of 14 MPa and elongation of<br>500% before aging and 400%<br>after aging. | Similar |
|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Biological<br>evaluation of<br>medical devices –<br>Part 10: Test for<br>irritation and skin<br>sensitization | Under the conditions of the study<br>the subject device extracts (polar<br>and non-polar) were not found to<br>cause a sensitizing response or an<br>irritation response in the animal<br>model. | Under the conditions of the study<br>the predicate device extracts<br>(polar and non-polar) were not<br>found to cause a sensitizing<br>response or an irritation response<br>in the animal model. | Same |
| Biological<br>evaluation of<br>medical devices –<br>Part 11: Tests for<br>Systemic Toxicity | Under the condition of the study the<br>subject device extracts (polar and<br>non-polar) were not found to caus e<br>a systemic response in the animal<br>model | Data not available from<br>manufacturer | Different |
| Conclusion: | Performance data support the conclusion that the subject device is as safe, as<br>effective, and performs as well as the legally marketed device that was<br>submitted and cleared under K172525. | | |