Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K192241 · O&M Haylard, Inc. · LZA · Mar 13, 2020 · General Hospital

Device Facts

• Record ID: K192241
• Device Name: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: O&M Haylard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices 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 and Fentanyl Citrate as per ASTM -D6978-05 : Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacıtıdine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladiibine (1 0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabıne HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthıough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Ep11 ubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabıne (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthıough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Iiinotecan (20 mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0 5 mg/ml) No breakthrough up to 240 mınutes Mitoxantıone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatın (2 mg/ml) No breaktlı ough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatın (10 mg/ml) No breakthrough up to 240 mınutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Pertuzumab (30 mg/ml) No breakthrough up to 240 mınutes Raltitlexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovii (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsuolimus (25 mg/ml) No breakthrough up to 240 minutes Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes

Device Story

Disposable, sterile, purple-colored, chlorinated, nitrile, powder-free, textured-fingertip, ambidextrous patient examination gloves. Used by clinicians to prevent cross-contamination between examiner and patient. Tested for permeation resistance against chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Provides barrier protection; reduces risk of exposure to hazardous drugs and opioids during clinical handling.

Clinical Evidence

Clinical evidence includes a 204-subject study using the Jordan-King modification of the Draize test to evaluate Type IV allergic contact sensitization. Results showed the device was non-irritating and induced no clinical evidence of residual chemical additives causing Type IV allergy. Non-clinical testing included ASTM D6319, D5151, D6124, D6978, and ISO 10993 (systemic toxicity, irritation, sensitization).

Technological Characteristics

Nitrile material; powder-free (ASTM D6124); textured fingertips; ambidextrous; sterile. Dimensions and physical properties (tensile strength, elongation) meet ASTM D6319. Biocompatibility per ISO 10993. Permeation resistance tested per ASTM D6978-05.

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 permeation by specific chemotherapy drugs and Fentanyl Citrate.

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* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) (K102032)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 13, 2020

O & M Halyard, Inc. Steven Dowdley Associate Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004

Re: K192241

Trade/Device Name: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves 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 10, 2020 Received: February 12, 2020

Dear Steven Dowdley:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K192241 Device Name

The Halyard Puple Xtra Steile, Low Dermatitis Potential Nitule Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citiate

#### Indications for Use (Describe)

The Halyad Purple Xtra Steile, Low Dermatitis Potental Nutile Powder-Fiee Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citateis are disposable devices intended for medical purposes that is worn on the examinel's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05 :

Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacıtıdine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladiibine (1 0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabıne HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthıough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Ep11 ubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabıne (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthıough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Iiinotecan (20 mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0 5 mg/ml) No breakthrough up to 240 mınutes Mitoxantıone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatın (2 mg/ml) No breaktlı ough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatın (10 mg/ml) No breakthrough up to 240 mınutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes

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Pertuzumab (30 mg/ml) No breakthrough up to 240 mınutes Raltitlexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovii (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsuolimus (25 mg/ml) No breakthrough up to 240 minutes Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes

Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes

Type of Use (Select one or both, as applicable)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green.

## 510(k) Summary – K192241

| Date Summary<br>was Prepared | March 12, 2020 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc.<br>5405 Windward Parkway<br>Alpharetta, GA 30004 |
| Primary Contact for<br>this 510(k) Submission | Steven Dowdley, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Device Trade Name | Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free Exam<br>Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| | Halyard Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZA<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove |
| Subsequent Product Codes | LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove, Specialty<br>QDO<br>Class I, 21 CFR §880.6250<br>Fentanyl and other opioid protection glove |
| Predicate Device | K102032<br>KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE<br>EXAM GLOVE (CHEMOTHERAPY GLOVE) |
| Subject Device Description | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-<br>Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl<br>Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free,<br>textured fingertip, ambidextrous, sterile patient examination gloves.<br>The devices follow 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 Gloves<br>for Medical Applications<br>• ASTM D6124-06 Standard Test Method for Residual Powder on Medical<br>Gloves<br>· ASTM D6978-05 Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy Drugs<br>· ISO 10993-11:2017, Biological evaluation of medical devices - Part 11:<br>Tests for Systemic Toxicity<br>· ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10:<br>Tests for Irritation and Skin Sensitization |

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Image /page/5/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, block letters. The design inside the circle appears to be two stylized shapes, one white and one green.

| Indications for Use | | The Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-<br>Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl<br>Citrate are disposable devices intended for medical purposes that is worn on<br>the examiner's hand to prevent contamination between patient and examiner.<br>These gloves were tested for use with the following chemotherapy drugs and<br>Fentanyl Citrate as per ASTM -D6978-05:<br>Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes<br>Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes<br>Bendamustine (5 mg/ml) No breakthrough up to 240 minutes<br>Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes<br>Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes<br>Busulfan (6 mg/ml) No breakthrough up to 240 minutes<br>Carboplatin (10 mg/ml) No breakthrough up to 240 minutes<br>Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes<br>Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes<br>Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes<br>Cisplatin (1 mg/ml) No breakthrough up to 240 minutes<br>Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes<br>Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes<br>Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes<br>Cytovene (10 mg/ml) No breakthrough up to 240 minutes<br>Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes<br>Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes<br>Decitabine (5 mg/ml) No breakthrough up to 240 minutes<br>Docetaxel (10 mg/ml) No breakthrough up to 240 minutes<br>Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes<br>Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes<br>Etoposide (20 mg/ml) No breakthrough up to 240 minutes<br>Fludarabine (25 mg/ml) No breakthrough up to 240 minutes<br>Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes<br>Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes<br>Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes<br>Idarubicin (1 mg/ml) No breakthrough up to 240 minutes<br>Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes<br>Irinotecan (20 mg/ml) No breakthrough up to 240 minutes<br>Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes<br>Melphalan (5 mg/ml) No breakthrough up to 240 minutes<br>Methotrexate (25 mg/ml) No breakthrough up to 240 minutes<br>Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes<br>Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes<br>Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes<br>Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes<br>Paraplatin (10 mg/ml) No breakthrough up to 240 minutes<br>Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes<br>Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes<br>Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes<br>Retrovir (10 mg/ml) No breakthrough up to 240 minutes<br>Rituximab (10 mg/ml) No breakthrough up to 240 minutes<br>Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes<br>Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes<br>ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes<br>Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes<br>Triclosan (1 mg/ml) No breakthrough up to 240 minutes<br>Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes<br>Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes<br>Vinblastine (1 mg/ml) No breakthrough up to 240 minutes<br>Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes | Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes |
|---------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes. | | |

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Image /page/6/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, bold letters. The design inside the circle appears to be two curved shapes, one white and one green, resembling sails or stylized mountains.

# Technological Characteristics Comparison Table

| | Subject Device | Predicate Device | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K192241 | K102032 | |
| FDA Product Code | LZA, LZC, QDO | LZC, LZA | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Purple Xtra and<br>Purple Sterile, Low<br>Dermatitis Potential,<br>Powder-Free Exam<br>Gloves Tested for Use<br>with Chemotherapy<br>Drugs and Fentanyl<br>Citrate | Kimberly Clark Purple Xtra<br>and Purple Sterile, Powder-<br>Free Exam Gloves Tested for<br>Use with Chemotherapy<br>Drugs | Same |
| Intended Use | The Halyard Purple Xtra<br>and Purple Sterile, Low<br>Dermtatis Potential,<br>Powder-Free Exam<br>Gloves Tested for Use<br>with Chemotherapy<br>Drugs and Fentanyl<br>Citrates are disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs<br>listed on the label. | Kimberly Clark Purple Xtra<br>and Purple Sterile, Powder-<br>Free Exam Gloves Tested for<br>Use with Chemotherapy<br>Drugs are disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>listed on the label. | Different |
| Technological<br>Characteristics | The glove is a colored,<br>nitrile, powder-free,<br>textured fingertip,<br>ambidextrous, patient<br>examination glove. | The glove is a colored, nitrile,<br>powder-free, textured<br>fingertip, ambidextrous,<br>patient examination glove. | Same |
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | Based ISO 10993<br>Biological evaluation of<br>Medical devices - Test<br>for Systemic Injection,<br>the test article was<br>considered non-toxic.<br>Meets the acceptance<br>criteria. | Based ISO 10993 Biological<br>evaluation of Medical devices<br>- Test for Systemic Injection,<br>the test article was<br>considered non-toxic. Meets<br>the acceptance criteria. | Same |
| | Based on ISO 10993-<br>Biological evaluation of<br>Medical Devices – Test<br>for Skin Irritation, the<br>device extracts were not<br>found to cause a<br>systemic response in the<br>animal model. Meets the<br>acceptance criteria. | Based on ISO 10993-<br>Biological evaluation of<br>Medical Devices - Test for<br>Skin Irritation, the device<br>extracts were not found to<br>cause a systemic response in<br>the animal model. Meets the<br>acceptance criteria. | |

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Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two curved shapes, one white and one green, creating a stylized image.

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Image /page/8/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two stylized shapes, one white and one green, resembling sails or stylized mountains.

| Standard | Results<br>Subject Devices | Results<br>Predicate Devices K102032 | Remarks |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|---------|
| ASTM D6978-05<br>Standard<br>Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves<br>to Permeation by<br>Chemotherapy<br>Drugs | Arsenic Trioxide (1 mg/ml) No<br>breakthrough up to 240 minutes | Bleomycin sulfate (15 mg/ml) No<br>breakthrough up to 240 minutes | Similar |
| | Azacitidine (Vidaza) (25 mg/ml) No<br>breakthrough up to 240 minutes | Busulfan (6 mg/ml) No breakthrough up to<br>240 minutes | |
| | Bendamustine (5 mg/ml) No<br>breakthrough up to 240 minutes | Carboplatin (10 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Bortezomib (Velcade) (1 mg/ml) No<br>breakthrough up to 240 minutes | Carmustine (3.3 mg/ml) permeation<br>occurred at 48.6 minutes | |
| | Bleomycin sulfate (15 mg/ml) No<br>breakthrough up to 240 minutes | Cyclophosphamide (20 mg/ml) No<br>breakthrough up to 240 minutes | |
| | Busulfan (6 mg/ml) No breakthrough up<br>to 240 minutes | Cytarabine HCL (100 mg/ml) No<br>breakthrough up to 240 minutes | |
| | Carboplatin (10 mg/ml) No breakthrough<br>up to 240 minutes | Dacarbazine (10 mg/ml) No breakthrough<br>up to 240 minutes | |
| | Carfilzomib (2 mg/ml) No breakthrough<br>up to 240 minutes | Daunorubicin HCL (5 mg/ml) No<br>breakthrough up to 240 minutes | |
| | Carmustine (3.3 mg/ml) permeation<br>occurred at 169.8 minutes | Docetaxel (10 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Cetuximab (Erbitux) (2 mg/ml) No<br>breakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml) No<br>breakthrough up to 240 minutes | |
| | Cisplatin (1 mg/ml) No breakthrough up<br>to 240 minutes | Epirubicin (Ellence) (2 mg/ml) No<br>breakthrough up to 240 minutes | |
| | Cladribine (1.0 mg/ml) No breakthrough<br>up to 240 minutes | Etoposide (20 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Cyclophosphamide (20 mg/ml) No<br>breakthrough up to 240 minutes | Fludarabine (25 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Cytarabine HCL (100 mg/ml) No<br>breakthrough up to 240 minutes | Fluorouracil (50 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Cytovene (10 mg/ml) No breakthrough<br>up to 240 minutes | Gemcitabine (38 mg/ml) No breakthrough<br>up to 240 minutes | |
| | Dacarbazine (10 mg/ml) No<br>breakthrough up to 240 minutes | Idarubicin (1 mg/ml) No breakthrough up to<br>240 minutes | |
| | Daunorubicin HCL (5 mg/ml) No<br>breakthrough up to 240 minutes | Ifosfamide (50 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Decitabine (5 mg/ml) No breakthrough<br>up to 240 minutes | Irinotecan (20 mg/ml) No breakthrough up<br>to 240 minutes | |
| | Docetaxel (10 mg/ml) No breakthrough<br>up to 240 minutes | Mechlorethamine HCL (1 mg/ml) No<br>breakthrough up to 240 minutes | |

{9}------------------------------------------------

# HALYARD

| Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes | Melphalan (5 mg/ml) No breakthrough up to 240 minutes |
|---------------------------------------------------------------------|------------------------------------------------------------------|
| Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes | Methotrexate (25 mg/ml) No breakthrough up to 240 minutes |
| Etoposide (20 mg/ml) No breakthrough up to 240 minutes | Mitomycin (0.5 mg/ml) No breakthrough up to 240 minutes |
| Fludarabine (25 mg/ml) No breakthrough up to 240 minutes | Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes |
| Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes | Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes |
| Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes | Paraplatin (10 mg/ml) No breakthrough up to 240 minutes |
| Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes | Rituximab (10 mg/ml) No breakthrough up to 240 minutes |
| Idarubicin (1 mg/ml) No breakthrough up to 240 minutes | ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes |
| Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes | Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes |
| Irinotecan (20 mg/ml) No breakthrough up to 240 minutes | Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes |
| Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes | |
| Melphalan (5 mg/ml) No breakthrough up to 240 minutes | |
| Methotrexate (25 mg/ml) No breakthrough up to 240 minutes | |
| Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes | |
| Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes | |
| Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes | |
| Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes | |
| Paraplatin (10 mg/ml) No breakthrough up to 240 minutes | |
| Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes | |
| Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes | |
| Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes | |
| Retrovir (10 mg/ml) No breakthrough up to 240 minutes | |
| Rituximab (10 mg/ml) No breakthrough<br>up to 240 minutes | |
| Temsirolimus (25 mg/ml) No<br>breakthrough up to 240 minutes | |
| Trastuzumab (21 mg/ml) No<br>breakthrough up to 240 minutes | |
| ThioTEPA (10 mg/ml) No breakthrough<br>up to 240 minutes | |
| Topotecan HCL (1 mg/ml) No<br>breakthrough up to 240 minutes | |
| Triclosan (1 mg/ml) No breakthrough up<br>to 240 minutes | |
| Trisenox (0.1 mg/ml) No breakthrough<br>up to 240 minutes | |
| Vincrinstine Sulfate (1 mg/ml) No<br>breakthrough up to 240 minutes | |
| Vinblastine (1 mg/ml) No breakthrough<br>up to 240 minutes | |
| Vinorelbine (10 mg/ml) No breakthrough<br>up to 240 minutes | |
| Zoledronic Acid (0.8 mg/ml) No<br>breakthrough up to 240 minutes | |

{10}------------------------------------------------

## HALYARD 11

| Performance Data for Fentanyl Citrate Injection | | | |
|-------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------|-----------|
| Standard | Results<br>Subject Devices | Results<br>Predicate Devices K102032 | Remarks |
| ASTM D 6978 | Fentanyl Citrate Injection, (100mcg<br>/2mL). No breakthrough up to 240<br>minutes | Not tested | Different |

| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>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. | 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. | Same |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|

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Image /page/11/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green, resembling stylized sails or mountains.

| ASTM D6124-06<br>Standard Test<br>Method for<br>Residual Powder<br>on Medical<br>Gloves | Residual powder on the subject<br>device is an average of 0.4<br>mg/glove within the powder-free limit<br>of < 2 mg maximum powder per<br>glove and meets the acceptance<br>criteria for powder- free. | Residual powder on the subject device<br>is an average of 0.4 mg/glove within<br>the powder-free limit of < 2 mg<br>maximum powder per glove and meets<br>the acceptance criteria for powder-<br>free. | Same |
|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 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 are within the limits of<br>the standard and the physical<br>properties of the subject device met<br>the requirements for tensile strength<br>before and after aging. The subject<br>device also met the requirement for<br>elongation before and after aging. | The physical dimensions of the subject<br>device are within the limits of the<br>standard and the physical properties of<br>the subject device met the<br>requirements for tensile strength<br>before and after aging. The subject<br>device also met the requirement for<br>elongation before and after aging. | Same |
| ISO 10993<br>Biological<br>evaluation of<br>medical devices | Meets acceptance criteria | Meets acceptance criteria | Same |

## Non- Clinical Testing Summary

## PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE:

| Brief description<br>of non-clinical<br>tests: | Test | Standard | Acceptance Criteria | Results |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dimensions | ASTM D 6319 | Length $\geq$ 230mm<br>Palm width Size<br>Xtra-Small: 60 – 80 mm<br>Small: 70 – 90 mm<br>Medium: 85 – 105 mm<br>Large: 100 – 120 mm<br>Xtra-Large: 110-130 mm<br>Finger Thickness<br>$\geq$ 0.050 mm<br>Palm Thickness<br>$\geq$ 0.050 mm<br>Cuff Thickness<br>0.10-0.13 mm (Halyard) | The physical<br>dimensions of the<br>subject device are<br>within the limits of the<br>standard. |
| | Physical Properties | ASTM D 6319 | AQL 4.0<br>Before<br>Tensile Strength: $\geq$ 14 MPa<br>Ultimate elongation: $\geq$ 500%<br>After<br>Tensile Strength: $\geq$ 14 MPa<br>Ultimate elongation: $\geq$ 400% | Physical properties<br>of the subject device<br>meet the<br>requirements for<br>tensile strength and<br>elongation in<br>the standard. |
| | Freedom from Pinholes | ASTM D 6319<br>ASTM D 5151 | AQL 2.5%<br>No leakage | Testing of the<br>subject device<br>shows it meets the<br>AQL requirement in<br>the<br>standards for leakage. |
| | Powder-Free | ASTM D 6124<br>ASTM D 6319 | $≤$ 2 mg / glove | Residual powder on<br>the subject device is<br>within the powder-<br>free limits prescribed<br>in the<br>standards. |
| | ISO Indirect Irritation<br>Study | ISO 10993, Part 10 | Primary Irritation Index<br>$\le$ 2.0 | Under the conditions of<br>the<br>study the device is<br>not an irritant. |
| | ISO Systemic Toxicity<br>Study | ISO 10993, Part 11 | No animals treated with test<br>extracts exhibit greater<br>reaction than control<br>animals | No evidence of<br>systemic toxicity. |
| | ISO Dermal<br>Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditions<br>of the study the<br>device is not a<br>sensitizer. |
| | Standard Practice for<br>Assessment of<br>Resistance of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs | ASTM D6978-05 | No breakthrough was detected<br>for up to 240 minutes | Acceptance criteria:<br>No signs of<br>breakthrough for the<br>subject device after 4<br>hours for 51<br>chemotherapy drugs.<br>Carmustine showed<br>no signs of<br>breakthrough until<br>169.8 minutes.<br>No signs of<br>breakthrough after 4<br>hours for Fentanyl<br>Citrate Injection<br>(100 mcg/2ml) |
| Brief description<br>of clinical tests: | A 204 subject study was completed to evaluate whether the level of residual chemical additives in the<br>subject device induced Type IV allergic contact sensitization by repetitive applications to the skin of<br>normal healthy human volunteers using the Jordan-King modification of the Draize test as<br>recommended by the FDA.<br>Under the conditions of the study, the subject device was nonirritating and showed no clinical<br>evidence of residual chemical additives that may induce Type IV allergy in human subject | | | |
| Conclusions: | The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject devices (the<br>Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential Powder-Free Exam Gloves Tested for<br>Use with Chemotherapy Drugs and Fentanyl Citrate) are as safe, as effective, and performs as well as<br>or better than the legally marketed devices cleared under K102032. | | | |

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Image /page/12/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, bold letters. The design inside the circle appears to be an abstract representation of a sail or a similar shape.