Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

K213937 · O&M Halyard, Inc. · LZA · Aug 16, 2022 · General Hospital

Device Facts

• Record ID: K213937
• Device Name: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
• Applicant: O&M Halyard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Aug 16, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)

Device Story

Disposable, lavender-colored, chlorinated, nitrile, powder-free, textured-fingertip, ambidextrous, non-sterile patient examination gloves; worn by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate/simulated gastric acid mixtures per ASTM D6978-05. Provides barrier protection; aids in clinical decision-making regarding safe handling of hazardous drugs. Benefits patient and examiner by reducing exposure to contaminants and hazardous substances.

Clinical Evidence

Clinical study (n=204) using Jordan-King modification of the Draize test evaluated potential for Type IV allergic contact sensitization. Results showed device was non-irritating and non-sensitizing, with no clinical evidence of residual chemical additives inducing Type IV allergy.

Technological Characteristics

Nitrile material; powder-free; chlorinated; textured fingertips; ambidextrous; non-sterile. Sizes: XS, S, M, L, XL. Color: Lavender. Biocompatibility per ISO 10993 (systemic toxicity, irritation, sensitization). Performance standards: ASTM D6319 (dimensions/physical properties), ASTM D5151 (leakage), ASTM D6124 (residual powder), ASTM D6978-05 (chemotherapy permeation).

Indications for Use

Indicated for use as a disposable medical exam glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and fentanyl citrate/simulated gastric acid mixtures per ASTM D6978-05. 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

• Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs (K202622)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".

August 16, 2022

O & M Halyard, Inc. Angela Bunn Director of Global Regulatory Affairs 1 Edison Drive Alpharetta, GA 30005

Re: K213937

Trade/Device Name: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: July 5, 2022 Received: July 11, 2022

Dear Angela Bunn:

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 mediation-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.

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213937

#### Device Name

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

#### Indications for Use (Describe)

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml)

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Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Warning: Not for Use With: Carmustine, ThioTEPA

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 contains a logo for Owens & Minor, a healthcare logistics company. The logo consists of a stylized "OM" in maroon, with horizontal lines within the letters. To the right of the "OM" is the company name "Owens & Minor" in gray. Below the logo is the text "510(k) Summary for K213937".

## This summary of 510(k) K213937 is being submitted in accordance with 21 CFR 807.92.

| Date Summary was Prepared | August 16, 2022 |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc.<br>1 Edison Drive<br>Alpharetta, GA 30005 |
| Primary Contact for<br>this 510(k) Submission | Angela L. Bunn, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Marketed Device Trade Name | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated<br>Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Device Submission Trade name<br>and Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated<br>Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove<br>LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty<br>OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| Predicate Device | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested<br>for Use with Chemotherapy Drugs (K202622) |
| Subject Device Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated<br>Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are<br>disposable, lavender colored, chlorinated, nitrile, powder-free, textured<br>fingertip, ambidextrous, non-sterile patient examination gloves. These<br>gloves will be available in sizes Extra Small, Small, Medium, Large and Extra<br>Large. |
| Indications for Use | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated<br>Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable<br>devices intended for medical purposes that is worn on the examiner's hand to<br>prevent contamination between patient and examiner. These gloves were<br>tested for use with the following chemotherapy drugs, Fentanyl Citrate and<br>Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as<br>per ASTM -D6978-05 :<br>The following chemotherapy drugs and concentration had NO breakthrough<br>detected up to 240 minutes:<br>Azacitidine (25 mg/ml)<br>Bendamustine HCl (5 mg/ml)<br>Bleomycin Sulfate (15 mg/ml)<br>Bortezomib (1 mg/ml)<br>Busulfan (6 mg/ml)<br>Capecitabine (26 mg/ml)<br>Carboplatin (10 mg/ml)<br>Carlzomib (2 mg/ml)<br>Cetuximab (2 mg/ml)<br>Chloroquine (50 mg/ml)<br>Cisplatin (1 mg/ml)<br>Cladribine (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Cyclosporin A (100 mg/ml)<br>Cytarabine (Cytosine) (100 mg/ml)<br>Cytovene (Ganciclovir) (10 mg/ml)<br>Dacarbazine (DTIC) (10 mg/ml)<br>Dactinomycin (0.5 mg/ml)<br>Daunorubicin HCl (5 mg/ml)<br>Decitabine (5 mg/ml)<br>Docetaxel (10 mg/ml)<br>Doxorubicin HCl (2 mg/ml)<br>Epirubicin HCI (Ellence) (2 mg/ml)<br>Etoposide (Toposar) (20 mg/ml)<br>Fludarabine (25 mg/ml)<br>5-Fluorouracil (50 mg/ml)<br>Fulvestrant (50 mg/ml)<br>Gemcitabine (38 mg/ml)<br>Idarubicin (1 mg/ml)<br>Ifosfamide (50 mg/ml)<br>Irinotecan HCl (20 mg/ml)<br>Leuprolide Acetate Salt (5 mg/ml)<br>Mechlorethamine HCl (1 mg/ml)<br>Melphalan (5 mg/ml)<br>Methotrexate (25 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2 mg/ml)<br>Oxaliptin (5 mg/ml)<br>Paclitaxel (6 mg/ml) |
| | |
| Pemetrexed (25 mg/ml) | |
| Raltitrexed (0.5 mg/ml) | |
| Retrovir (10 mg/ml) | |
| Rituximab (10 mg/ml) | |
| Temsirolimus (25 mg/ml) | |
| Topotecan HCl (1 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Trisenox (1 mg/ml) | |
| Vinblastine Sulfate (1 mg/ml) | |
| Vincristine (1 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| | |
| The following chemotherapy drugs and concentration showed breakthrough | |
| detected in less than 60 minutes: | |
| Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. | |
| Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. | |
| | |
| The following hazardous drugs (opioids) and concentration had NO | |
| breakthrough detected up to 240 minutes: | |
| Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid | |
| Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| | |
| Warning: Not for Use With: Carmustine, Thiotepa | |
| | |
| Intended for Over-the-Counter use | |
| |…