Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

K191230 · O&M Halyard, Inc. · LZC · Nov 8, 2019 · General Hospital

Device Facts

• Record ID: K191230
• Device Name: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
• Applicant: O&M Halyard, Inc.
• Product Code: LZC · General Hospital
• Decision Date: Nov 8, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Sterling 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: [List of 52 drugs provided in document].

Device Story

Disposable, non-sterile, ambidextrous, grey-colored nitrile examination gloves; textured fingertips; powder-free. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Tested for permeation resistance against 52 chemotherapy drugs per ASTM D6978-05. Provides a physical barrier; protects the wearer from exposure to hazardous chemotherapy agents during handling. Packaged in cardboard dispenser boxes.

Clinical Evidence

Bench testing only. Testing included ASTM D5151-06 (leakage, 2.5% AQL), ASTM D6124-06 (residual powder < 2 mg/glove), ASTM D6319-10 (tensile strength/elongation), and ISO 10993 (systemic toxicity, dermal irritation, dermal sensitization). Chemotherapy drug permeation tested per ASTM D6978-05 for 52 drugs.

Technological Characteristics

Material: Nitrile. Form: 9.5-inch, 0.08 mm palm thickness, textured fingertips, ambidextrous, non-sterile. Standards: ASTM D6978-05 (chemo permeation), ASTM D5151-06 (leakage), ASTM D6124-06 (powder), ASTM D6319-10 (physical properties), ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand 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

• Halyard Lavender Nitrile Powder-Free Exam Gloves (K180646)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 8, 2019

O & M Halyard, Inc. Steve Dowdley Associate Director of Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K191230

Trade/Device Name: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZC Dated: July 19, 2019 Received: August 13, 2019

Dear Steve 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.

{1}------------------------------------------------

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 (OS) 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.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K191230

#### Device Name

Halyard Sterling Nitrile Powder-Free Exam Gloves

#### Indications for Use (Describe)

The Halyard Sterling 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:

Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes

{3}------------------------------------------------

Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml). No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes

ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known) K191230

#### Device Name

Halyard Sterling SG * Nitrile Sensi-Guard Powder-Free Exam Gloves

#### Indications for Use (Describe)

The Halyard Sterling SG* Nitrile Sensi-Guard 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:

Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes

{5}------------------------------------------------

Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes

ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Halyard, which is part of the Owens & Minor Family. The logo consists of a circular emblem with a stylized white and green shape inside, followed by the word "HALYARD" in bold, dark blue letters. Below the company name, the text "Part of the Owens & Minor Family" is written in a smaller, lighter font.

## 510(k) Summary

| Date Summary<br>was Prepared | Nov 4, 2019 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Owens & Minor Halyard, Inc<br>9120 Lockwood Blvd<br>Mechanicsville, VA 23116 |
| Primary Contact for<br>this 510(k) Submission | Steven Dowdley, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Device Trade Name | Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves<br>and<br>Halyard STERLING* Nitrile Powder-Free Exam Gloves |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove |
| Predicate Device | K180646<br>Halyard Lavender Nitrile Powder-Free Exam Gloves |
| Subject Device Description | Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free<br>Exam Gloves and Halyard STERLING* Nitrile Powder-Free<br>Exam Gloves tested for Use with Chemotherapy Drugs are<br>disposable, grey-colored, chlorinated, nitrile, powder-free,<br>textured fingertip, ambidextrous, non-sterile patient<br>examination gloves that are packed in a cardboard<br>dispenser box. |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue, block letters. Below the word "HALYARD" is the phrase "Part of the Owens & Minor Family" in a smaller font.

| Indications for Use for<br>Halyard Sterling SG* Nitrile<br>Sensi-Guard Powder-Free<br>Exam Gloves | The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves are<br>disposable devices intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between patient and examiner.<br>These gloves were tested for use with the following chemotherapy drugs: |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes |
| | Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes |
| | Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes |
| | Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes |
| | Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes |
| | Paraplatin (10 mg/ml), No breakthrough up to 240 minutes |
| | Bendamustine (5 mg/ml), No breakthrough up to 240 minutes |
| | Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes |
| | Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes |
| | Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes |
| | Etoposide (20 mg/ml), No breakthrough up to 240 minutes |
| | Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes |
| | Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes |
| | Fludarabine (25 mg/ml), No breakthrough up to 240 minutes |
| | Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes |
| | Busulfan (6 mg/ml), No breakthrough up to 240 minutes |
| | Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, No<br>breakthrough up to 240 minutes |
| | Retrovir (10 mg/ml) No breakthrough up to 240 minutes |
| | Carboplatin (10 mg/ml), No breakthrough up to 240 minutes |
| | Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes |
| | Rituximab (10 mg/ml), No breakthrough up to 240 minutes |
| | Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes |
| | Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes |
| | Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes |
| | Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes |
| | Idarubicin (1 mg/ml), No breakthrough up to 240 minutes |
| | Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes |
| | Cisplatin (1 mg/ml), No breakthrough up to 240 minutes |
| | Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes |
| | Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes |
| | Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes |
| | Irinotecan (20 mg/ml), No breakthrough up to 240 minutes |
| | Triclosan (2 mg/ml), No breakthrough up to 240 minutes…