HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

K160709 · Halyard Health · LZC · Sep 6, 2016 · General Hospital

Device Facts

• Record ID: K160709
• Device Name: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
• Applicant: Halyard Health
• Product Code: LZC · General Hospital
• Decision Date: Sep 6, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves tested for use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed break through at 80.4 minutes.

Device Story

Disposable, 12-inch, purple-colored, nitrile, powder-free, textured-fingertip, ambidextrous, non-sterile patient examination gloves. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Device provides a barrier against various chemotherapy drugs. Increased thickness compared to predicate improves permeation resistance, specifically extending Carmustine breakthrough time to 80.4 minutes and adding 23 additional chemotherapy drugs to the resistance claim. Output is a physical barrier; healthcare providers use the glove during patient examinations and chemotherapy handling to protect themselves from exposure to hazardous drugs and biological contaminants.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (leakage/holes), ASTM D6319-10 (physical properties/dimensions), and ASTM D6124-06 (residual powder).

Technological Characteristics

Material: Nitrile. Form factor: 12-inch, powder-free, textured fingertip, ambidextrous, non-sterile. Thickness: 0.11-0.19mm (finger), 0.11-0.16mm (palm). Conforms to ASTM D6319-10, ASTM D6978-05, ASTM D5151-06, and ASTM D6124-06.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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

• Kimberly-Clark PURPLE NITRILE –XTRA* Powder-Free Exam Glove tested for use with chemotherapy drugs - 12" Length (K113423)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Haylard Health Gwendolyn George Regulatory Affairs, Technical Leader 5405 Windward Parkway Alpharetta, Georgia 30004

Re: K160709 Trade/Device Name: HAYLARD* PURPLE NITRILE – XTRA* Powder Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: August 3, 2016 Received: August 4, 2016

Dear Ms. Gwendolyn George:

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, 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.

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Michae DVRyan -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K160709

Device Name

HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves

#### Indications for Use (Describe)

HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes

| ChemoTherapy<br>Drug (conc.) | Break-<br>through<br>Time (mins) | ChemoTherapy<br>Drug (conc.) | Break-<br>through<br>Time (mins) | ChemoTherapy<br>Drug (conc.) | Break-<br>through<br>Time (mins) |
|------------------------------------|----------------------------------|----------------------------------|----------------------------------|-----------------------------------|----------------------------------|
| Arsenic Trioxide<br>(1 mg/ml) | > 240 | Doxorubicin HCI<br>(2 mg/ml) | > 240 | Paraplatin<br>(10 mg/ml) | > 240 |
| Azacitidine (Vidaza)<br>(25 mg/ml) | > 240 | Ellence<br>(2 mg/ml) | > 240 | Pemetrexed<br>(25 mg/ml) | > 240 |
| Bendamustine<br>(5 mg/ml) | > 240 | Eribulin Mesylate<br>(0.5 mg/ml) | > 240 | Pertuzumab<br>(30 mg/ml) | > 240 |
| Bleomycin sulfate<br>(15 mg/ml) | > 240 | Etoposid<br>(20 mg/ml) | > 240 | Raltitrexed<br>(0.5 mg/ml) | > 240 |
| Bortezomib (Velcade)<br>(1 mg/ml) | > 240 | Fludarabine<br>(25 mg/ml) | > 240 | Retrovir<br>(10 mg/ml) | > 240 |
| Busulfan<br>(6 mg/ml) | > 240 | Fulvestrant<br>(50 mg/ml) | > 240 | Rituximab<br>(10 mg/ml) | > 240 |
| Carfilzomib<br>(2 mg/ml) | > 240 | Fluorouracil<br>(50 mg/ml) | > 240 | Temsirolimus<br>(25 mg/ml) | > 240 |
| Carboplatin<br>(10 mg/ml) | > 240 | Gemcitabine<br>(38 mg/ml) | > 240 | ThioTEPA<br>(10 mg/ml) | > 240 |
| Carmustine<br>(3.3 mg/ml) | 80.4 | Idarubicin<br>(1 mg/ml) | > 240 | Topotean HCI<br>(1 mg/ml) | > 240 |
| Cetuximab (Erbitux)<br>(2 mg/ml) | > 240 | Ifosfamide<br>(50 mg/ml) | > 240 | Trastuzumab<br>(21 mg/ml) | > 240 |
| Cisplatin<br>(1 mg/ml) | > 240 | Irinotecan<br>(20 mg/ml) | > 240 | Triclosan<br>(1 mg/ml) | > 240 |
| Cyclophosphamide<br>(20 mg/ml) | > 240 | Mechlorethamine<br>HCl (1 mg/ml) | > 240 | Trisenox<br>(0.1 mg/ml) | > 240 |
| Cytarabine HCI<br>(100 mg/ml) | > 240 | Melphalan<br>(5 mg/ml) | > 240 | Vinblastine<br>(1 mg/ml) | > 240 |
| Cytovene<br>(10 mg/ml) | > 240 | Methotrexate<br>(25 mg/ml) | > 240 | Vincrinstine Sulfate<br>(1 mg/ml) | > 240 |
| Dacarbazine<br>(10 mg/ml) | > 240 | Mitomycin<br>(0.5 mg/ml) | > 240 | Vinorelbine<br>(10 mg/ml) | > 240 |
| Daunorubicin Hcl<br>(5 mg/ml) | > 240 | Mitoxantrone<br>(2 mg/ml) | > 240 | Zoledronic Acid<br>(0.8 mg/ml) | > 240 |
| Decitabine<br>(5 mg/ml) | > 240 | Oxaliplatin<br>(2mg/ml) | > 240 | | |
| Docetaxel<br>(10 mg/ml) | > 240 | Paclitaxel<br>(6 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)

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# 510(k) Summary

| Date Summary<br>was Prepared: | September 6, 2016 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Gwendolyn George<br>Technical Leader, Regulatory Affairs<br>Halyard Health<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>Email: [e-mail]<br>Ph: 520-204-6442<br>Establishment Registration Number 3011270181 |
| Primary Contact for<br>this 510(k)<br>Submission: | Gwendolyn George<br>Technical Leader, Regulatory Affairs<br>Halyard Health<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>Email: [e-mail]<br>Ph: 520-204-6442 |
| Device Trade Name: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves |
| Device Common<br>Name: | Medical Exam Gloves |
| Device Product Code<br>and Classification<br>Name: | LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove, Specialty |
| Predicate Device: | K113423<br>Kimberly-Clark PURPLE NITRILE –XTRA* Powder-Free Exam Glove tested<br>for use with chemotherapy drugs - 12" Length |
| Subject Device<br>Description: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12"<br>disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous,<br>non-sterile patient examination gloves that have been tested for use with<br>chemotherapy drugs. |
| Intended Use: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves tested for<br>use with Chemotherapy Drugs are powder-free patient examination gloves that<br>are a disposable device intended for medical purposes worn on the examiner's<br>hand or finger to prevent contamination between patient and examiner. This is<br>an over the counter medical device. The HALYARD* PURPLE NITRILE –<br>XTRA* Powder-Free Exam Gloves have been tested with the following<br>Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine<br>showed break through at 80.4 minutes. |

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# Halyard Health 510(k) for the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves`

| | Break-<br>through<br>Time<br>(mins) | ChemoTherapy<br>Drug (conc.) | Break-<br>through<br>Time<br>(mins) | ChemoTherapy<br>Drug (conc) | Break-<br>through<br>Time<br>(mins) |
|---------------------------------------|-------------------------------------|----------------------------------|-------------------------------------|--------------------------------------|-------------------------------------|
| ChemoTherapy<br>Drug (conc.) | | | | | |
| Arsenic Trioxide<br>(1 mg/ml) | > 240 | Doxorubicin HCI<br>(2 mg/ml) | > 240 | Paraplatin<br>(10 mg/ml) | > 240 |
| Azacitidine<br>(Vidaza) (25<br>mg/ml) | > 240 | Ellence<br>(2 mg/ml) | > 240 | Pemetrexed<br>(25 mg/ml) | > 240 |
| Bendamustine<br>(5 mg/ml) | > 240 | Eribulin Mesylate<br>(0.5 mg/ml) | > 240 | Pertuzumab<br>(30 mg/ml) | > 240 |
| Bleomycin sulfate<br>(15 mg/ml) | > 240 | Etoposid<br>(20 mg/ml) | > 240 | Raltitrexed<br>(0.5 mg/ml) | > 240 |
| Bortezomib<br>(Velcade) (1<br>mg/ml) | > 240 | Fludarabine<br>(25 mg/ml) | > 240 | Retrovir<br>(10 mg/ml) | > 240 |
| Busulfan<br>(6 mg/ml) | > 240 | Fulvestrant<br>(50 mg/ml) | > 240 | Rituximab<br>(10 mg/ml) | > 240 |
| Carfilzomib<br>(2 mg/ml) | > 240 | Fluorouracil<br>(50 mg/ml) | > 240 | Temsirolimus<br>(25 mg/ml) | > 240 |
| Carboplatin<br>(10 mg/ml) | > 240 | Gemcitabine<br>(38 mg/ml) | > 240 | ThioTEPA<br>(10 mg/ml) | > 240 |
| Carmustine<br>(3.3 mg/ml) | 80.4 | Idarubicin<br>(1 mg/ml) | > 240 | Topotean HCl<br>(1 mg/ml) | > 240 |
| Cetuximab<br>(Erbitux)<br>(2 mg/ml) | > 240 | Ifosfamide<br>(50 mg/ml) | > 240 | Trastuzumab<br>(21 mg/ml) | > 240 |
| Cisplatin<br>(1 mg/ml) | > 240 | Irinotecan<br>(20 mg/ml) | > 240 | Triclosan<br>(1 mg/ml) | > 240 |
| Cyclophosphamide<br>(20 mg/ml) | > 240 | Mechlorethamine<br>HCl (1 mg/ml) | > 240 | Trisenox<br>(0.1 mg/ml) | > 240 |
| Cytarabine HCI<br>(100 mg/ml) | > 240 | Melphalan<br>(5 mg/ml) | > 240 | Vinblastine<br>(1 mg/ml) | > 240 |
| Cytovene<br>(10 mg/ml) | > 240 | Methotrexate<br>(25 mg/ml) | > 240 | Vincrinstine<br>Sulfate (1<br>mg/ml) | > 240 |
| Dacarbazine<br>(10 mg/ml) | > 240 | Mitomycin<br>(0.5 mg/ml) | > 240 | Vinorelbine<br>(10 mg/ml) | > 240 |
| Daunorubicin Hcl<br>(5 mg/ml) | > 240 | Mitoxantrone<br>(2 mg/ml) | > 240 | Zoledronic<br>Acid<br>(0.8 mg/ml) | > 240 |
| Decitabine<br>(5 mg/ml) | > 240 | Oxaliplatin<br>(2mg/ml) | > 240 | | |
| Docetaxel<br>(10 mg/ml) | > 240 | Paclitaxel<br>(6 mg/ml) | > 240 | | |

(Note within 510(k) Summary only: The difference between the subject and predicate devices' indications for use do not affect substantial equivalence.)

Summary of Technologies: The technological characteristics and intended use of the subject and predicate device are substantially equivalent. The subject device is increased in thickness. This change resulted in improved Carmustine permeation time of 80.4 minutes at a 3.3 mg/ml concentration and expanded chemotherapy drug resistance claim to 23 additional drugs as reflected in the table below.

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| F | Subject Device | Predicate Device<br>K113423 | Substantially<br>Equivalent |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| FDA Product Code | LZC | LZC | Yes |
| FDA Classification | Class 1 | Class 1 | Yes |
| Common Name | Medical Exam Glove | Medical Exam Glove | Yes |
| Device Trade Name | HALYARD* PURPLE NITRILE -<br>XTRA* Powder-Free Exam Gloves | Kimberly-Clark Purple Nitrile-XTRA<br>Powder-Free Exam Gloves - 12"<br>Length | Yes |
| Intended Use | HALYARD* PURPLE NITRILE -<br>XTRA* Powder-Free Exam Gloves<br>are 12" in length, a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand and finger to<br>prevent contamination between<br>patient and examiner. | The Kimberly-Clark Purple Nitrile-<br>XTRA Powder-Free Exam Glove<br>tested for use with chemotherapy<br>drugs -12" Length is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Yes |
| Technological<br>Characteristics | Purple colored, chlorinated, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, non - sterile patient<br>examination glove. | Purple colored, chlorinated, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, non- sterile patient<br>examination glove. | Yes |
| Performance Data | | | |
| ASTM D6978-05<br>Standard Practice for<br>Assessment of<br>Resistance of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | Acceptance criteria: No signs of<br>breakthrough after 4 hours.<br>Carmustine showed no signs of<br>breakthrough after 80.4 minutes<br>Result: No breakthrough observed.<br>Meets acceptance criteria. PASS | Acceptance criteria: No signs of<br>breakthrough after 4 hours.<br>Carmustine showed no signs of<br>breakthrough after 30.7 minutes<br>Result: No breakthrough observed.<br>Meets acceptance criteria. PASS | Yes |
| ASTM D5151-06<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | Testing of the subject device shows<br>it meets the 2.5% AQL requirement<br>in the standards for leakage. The<br>device meets the acceptance criteria<br>of the standard. PASS | Testing of the subject device shows it<br>meets the 2.5% AQL requirement in<br>the standards for leakage. The device<br>meets the acceptance criteria of the<br>standard. PASS | Yes |
| ASTM D6124-06<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | Residual powder on the subject<br>device is within the powder-free<br>limit of < 2 mg maximum powder<br>per glove and meets the<br>acceptance criteria for powder-<br>free. PASS | Residual powder on the subject<br>device is within the powder-free<br>limit of < 2 mg maximum powder<br>per glove and meets the<br>acceptance criteria for powder-free.<br>PASS | Yes |

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| | Subject Device | | | Predicate Device<br>K113423 | | | Substantially<br>Equivalent |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------------------------|-----------------------------|
| Performance Data<br>ASTM D6319-10<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Applications | The physical dimensions of the<br>subject device are within the limits<br>of the standard and the physical<br>properties of the subject device<br>meet the requirements for tensile<br>strength and elongation in the<br>standard. Therefore the device<br>meets the acceptance criteria of<br>the standard. PASS | | | The physical dimensions of the<br>subject device are within the limits<br>of the standard and the physical<br>properties of the subject device<br>meet the requirements for tensile<br>strength and elongation in the<br>standard. Therefore the device<br>meets the acceptance criteria of the<br>standard. PASS | | | Yes |
| | Property | ASTM | Halyard<br>Specification | Property | ASTM | Kimberly Clark<br>Specification | |
| | Holes | AQL 2.5% | AQL 1.0% | Holes | AQL 2.5% | AQL 1.0% | |
| | Length | ≥230 mm | 295-325 mm | Length | ≥230 mm | 295 -325 mm | |
| | Width | 85-105mm | 85-105mm | Width | 85-105mm | 85-105mm | |
| | Finger<br>Thickness | ≥0.05mm | 0.11- 0.19mm | Finger<br>Thickness | ≥0.05mm | 0.10- 0.19mm | |
| | Palm<br>Thickness | ≥0.05mm | 0.11 -0.16mm | Palm<br>Thickness | ≥0.05mm | 0.10 -0.16mm | |
| | Unaged<br>Tensile | ≥14 MPa | ≥14 MPa | Unaged<br>Tensile | ≥14 MPa | ≥14 MPa | |
| | Unaged<br>Elongation | ≥500% | ≥500% | Unaged<br>Elongation | ≥500% | ≥500% | |
| | Aged Tensile | ≥14 MPa | ≥14 MPa | Aged Tensile | ≥14 MPa | ≥14 MPa | |
| | Aged<br>Elongation | ≥400% | ≥500% | Aged<br>Elongation | ≥400% | ≥500% | |
| | Powder | ≤2mg/glove | ≤2mg/glove | Powder | ≤2mg/glove | ≤2mg/glove | |
| | The Halyard specifications listed above<br>conform to or exceed the ASTM D6319<br>Standard Specification. | | | The Kimberly Clark specifications listed<br>above conform to or exceed the ASTM<br>D6319 Standard Specification. | | | |
| ISO 10993-10 Biological<br>evaluation of medical<br>devices -Tests for<br>Irritation | Based on an evaluation | | | Acceptance criteria: No erythema/<br>edema up to 72 hours post exposure.<br>Result: Erythema/edema was<br>negligible. Meets acceptance criteria.<br>PASS | | | |
| ISO 10993-10 Biological<br>evaluation of medical<br>devices - Tests for Skin<br>Sensitization | according to ISO 10993-1, it<br>was determined that no<br>additional testing on the<br>subject glove was needed. | | | Acceptance criteria: No evidence<br>of delayed dermal contact sensitivity<br>at 24 and 48 hours post injection.<br>Result: Not a sensitizer under<br>conditions of the study. Meets<br>acceptance criteria. PASS | | | |
| ISO 10993-11 Biological<br>evaluation of medical<br>devices - Tests for<br>Systemic Toxicity | | | | Acceptance criteria: No signs of<br>systemic toxicity up to 72 hours post<br>injection.<br>Result: No systemic toxicity<br>observed. Meets acceptance criteria.<br>PASS | | | |
| Conclusion | The performance data support the conclusion that the subject device is as safe, as effective,<br>and performs as well as the legally marketed device that was submitted and cleared under<br>K113423. | | | | | | |

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The HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves were tested for use with the following drug concentrations per ASTM D6978-05. All study results were acceptable.

| Additional<br>Chemotherapeutic<br>Drugs tested | Drug<br>Concentration | Chemotherapeutic<br>Drugs Listed on<br>Predicate labeling | Drug<br>Concentration |
|------------------------------------------------|-----------------------|-----------------------------------------------------------|-----------------------|
| Arsenic Trioxide | 1 mg/ml | Bleomycin sulfate | 15 mg/ml |
| Azacitidine (Vidaza) | 25 mg/ml | Busulfan | 6 mg/ml |
| Bendamustine | 5 mg/ml | Carboplatin | 10 mg/ml |
| Bortezomib (Velcade) | 1 mg/ml | Cisplatin | 1 mg/ml |
| Carfilzomib | 2 mg/ml | Cyclophosphamide | 20 mg/ml |
| Cetuximab (Erbitux) | 2 mg/ml | Cytarabine HCI | 100 mg/ml |
| Cytovene | 10 mg/ml | Dacarbazine | 10 mg/ml |
| Decitabine | 5 mg/ml | Daunorubicin Hcl | 5 mg/ml |
| Eribulin Mesylate | 0.5 mg/ml | Docetaxel | 10 mg/ml |
| Fulvestrant | 50 mg/ml | Doxorubicin HCI | 2 mg/ml |
| Oxaliplatin | 2mg/ml | Ellence | 2 mg/ml |
| Paraplatin | 10 mg/ml | Etoposide | 20 mg/ml |
| Pemetrexed | 25 mg/ml | Fludarabine | 25 mg/ml |
| Pertuzumab | 30 mg/ml | Fluorouracil | 50 mg/ml |
| Raltitrexed | 0.5 mg/ml | Gemcitabine | 38 mg/ml |
| Retrovir | 10 mg/ml | Idarubicin | 1 mg/ml |
| Temsirolimus | 25 mg/ml | Ifosfamide | 50 mg/ml |
| Topotean HCl | 1 mg/ml | Irinotecan | 20 mg/ml |
| Trastuzumab | 21 mg/ml | Mechlorethamine HCI | 1 mg/ml |
| Triclosan | 1 mg/ml | Melphalan | 5 mg/ml |
| Vinblastine | 1 mg/ml | Methotrexate | 25 mg/ml |
| Vinorelbine | 10 mg/ml | Mitomycin | 0.5 mg/ml |
| Zoledronic Acid | 0.8 mg/ml | Mitoxantrone | 2 mg/ml |

## The following drugs had NO breakthrough detected up to 240 minutes:

Carmustine was retested on the subject device with breakthrough detected in 80.4 minutes at a concentration of 3.3 mg/ml. The predicate device had breakthrough detected at 30.7 minutes.

Paclitaxel

Rituximab

ThioTEPA

Vincrinstine Sulfate

Trisenox

6 mg/ml

10 mg/ml

10 mg/ml

0.1 mg/ml 1 mg/ml

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| Technological Characteristics<br>and Substantial Equivalence: | The HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam<br>Gloves is substantially equivalent to the predicate device,<br>Kimberly-Clark Purple Nitrile-XTRA Powder-Free Exam Gloves<br>tested for use with chemotherapy drugs (K113423). We are<br>submitting this 510(k) for clearance of expanded chemotherapy<br>drug claim on the product labeling based on testing in accordance<br>with ASTM D6978-05 for chemical permeation to twenty three (23)<br>additional chemotherapy drugs with improved permeation to<br>Carmustine. The test results demonstrate no new issues of safety<br>and efficacy. |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | These gloves have been tested for conformance to the applicable<br>sections of the following standards: |
| | ASTM D6978-05 Standard Practice for Assessment of Resistance<br>of Medical Gloves to Permeation by Chemotherapy Drugs |
| | ASTM D5151-06 Standard Test Method for Detection of Holes in<br>Medical Gloves |
| | ASTM D6319-10 Standard Specification for Nitrile Examination<br>Gloves for Medical Applications |
| | ASTM D6124-06 Standard Test Method for Residual Powder on<br>Medical Gloves |
| | ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA. |
| Brief Description of Clinical<br>Tests: | No new clinical tests were required to support this 510(k)<br>notification. |
| Conclusion: | The performance data support the conclusion that the subject<br>device is as safe, as effective, and performs as well as the<br>legally marketed device that was submitted and cleared under<br>K113423. |