Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

K213929 · O&M Halyard, Inc. · LZA · Aug 1, 2022 · General Hospital

Device Facts

• Record ID: K213929
• Device Name: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
• Applicant: O&M Halyard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Aug 1, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Purple Nitrile, Powder-Free Exam Gloves 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 and Gastric Acid 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 HCl (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) Oxaliplatin (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) Vinorelbine (10 mg/ml) Vincristine (1 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. Warning- Not for use with Carmustine and ThioTEPA No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Device Story

Disposable, powder-free, nitrile, textured-fingertip, ambidextrous, non-sterile patient examination glove; used by clinicians to prevent cross-contamination between patient and examiner. Device provides barrier protection against specific chemotherapy drugs, Fentanyl Citrate, and simulated gastric acid. Performance validated via ASTM D6978-05 permeation testing; breakthrough times measured for various hazardous drugs. Not for use with Carmustine or Thiotepa. Packaged in cardboard dispenser boxes.

Clinical Evidence

Bench testing only. No clinical data. Permeation testing per ASTM D6978-05 demonstrated no breakthrough for 50 chemotherapy drugs, Fentanyl Citrate, and Fentanyl/Gastric Acid mix up to 240 minutes. Biocompatibility testing (ISO 10993-10/11) confirmed non-irritant, non-sensitizing, and non-toxic status.

Technological Characteristics

Nitrile material; powder-free; textured fingertips; ambidextrous; non-sterile. Sizes: XS, S, M, L, XL. Standards: ASTM D6319 (physical properties/dimensions), ASTM D5151 (pinholes), ASTM D6124 (residual powder), ASTM D6978 (chemotherapy permeation). Biocompatibility per ISO 10993-10/11.

Indications for Use

Indicated for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs, Fentanyl Citrate, and simulated gastric acid.

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 Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs (K200633)

Submission Summary (Full Text)

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August 1, 2022

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

# Re: K213929

Trade/Device Name: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ, QDO Dated: June 28, 2022 Received: June 30, 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.

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

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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,

Clarence W. Murray, III, 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

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

#### 510(k) Number (if known)

#### K213929

#### Device Name

Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid Indications for Use (Describe)

The Halvard Purple Nitrile, Powder-Free Exam Gloven intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were the following chemotherapy drugs and Fentany Citrate and Gastric Acid as per ASTM-26978-05

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) Dactinomvcin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (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) Oxaliplatin (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) Vinorelbine (10 mg/ml) Vincristine (1 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:

Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.

Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.

Warning- Not for use with Carmustine and ThioTEPA

No breakthrough was detected up to 240 minutes for Fention (100 mg/2 ml) and Simulated Gastric Acid Fluid/Fentany Citrate hijection Mix 50/50 Solution

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

| Date Summary<br>was Prepared | July 28, 2022 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Clearance Number | K213929 |
| 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 Common Name | Halyard Purple Nitrile Powder-Free Exam Gloves |
| Device Submission Trade Name<br>and Description | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove<br>OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove<br>OPJ, Class 1, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling<br>Claims - Test For Use With Chemotherapy Drugs |
| Predicate Device | Halyard Purple , Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs (K200633) |
| Subject Device Description | The Halyard Purple Powder-Free Nitrile Exam Glove tested with<br>Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a<br>disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-<br>sterile patient examination glove that are chlorinated on the donning side<br>and are packed in a cardboard dispenser box.<br>The devices follow consensus standards:<br>ASTM D5151-06 Standard Test Method for Detection of Holes in Medical<br>Gloves<br>ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for<br>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 Medical<br>Gloves to Permeation by Chemotherapy Drugs<br>ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests<br>for Systemic Toxicity |
| ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: | |
| Tests for Irritation and Skin Sensitization | |
| Indications for Use | |
| The Halyard Purple Nitrile, Powder-Free Exam Gloves 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 and Gastric Acid 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 HCl (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) | |
| Oxaliplatin (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)…