Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical medical glove and the summary describes its material properties and testing against various chemicals, not any computational or analytical functions.

Therapeutic

No
The device is described as disposable exam gloves intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.

Diagnostic

No

The device is medical examination gloves, which are used for protection and to prevent contamination, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a physical medical glove, not a software application. The description clearly outlines its material, physical characteristics, and intended use as a barrier worn on the hand.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the gloves are "disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and infection control during medical examinations.
IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
Lack of Diagnostic Function: The description of the gloves and their testing for resistance to various substances (chemotherapy drugs, fentanyl, gastric acid) relates to their barrier properties and safety for the user, not to the diagnosis of any condition in a patient.
Performance Studies: The performance studies focus on the physical properties of the gloves (dimensions, pinholes, powder-free), biocompatibility (irritation, toxicity, sensitization), and resistance to permeation by certain substances. These are not diagnostic performance metrics.

In summary, the Halyard Purple Nitrile Exam Gloves are a medical device used for protection and contamination prevention, not for performing diagnostic tests on patient samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are 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) 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 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

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

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ, QDO

Device Description

The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing:
- Dimensions (ASTM D 6319): Length >=230 mm; Palm Width Size: X-Small: 60 – 80 mm, Small: 70 – 90 mm, Med: 85–105 mm, Large: 100 - 120 mm, X-Large: 110-130 mm, XX-Large: 120-140 mm; Finger, Palm, and Cuff thickness >=0.05 mm. Results: Meets requirements.
- Physical Properties (ASTM D 6319): AQL 4.0; Before Aging: Tensile Strength: >=14 MPa, Ultimate elongation: >=500%; After Aging: Tensile Strength: >=14 MPa, Ultimate elongation: >=400%. Results: Meets requirements.
- Freedom from Pinholes (ASTM D 6319, ASTM D 5151): AQL 2.5% No leakage. Results: Meets requirements.
- Powder Free (ASTM D 6124, ASTM D 6319):

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2024

O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K241909

Trade/Device Name: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential. 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, LZC, OPJ, ODO Dated: June 30, 2024 Received: July 1, 2024

Dear Caitlin Senter:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

2

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241909

Device Name

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

Indications for Use (Describe)

Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are 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) FORM FDA 3881 (8/23)

4

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) 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 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

The following hazardous drugs (opioids) and concentration had NO

breakthrough detected up to 240 minutes:

Fentanyl Citrate Injection (100 mcg/2 ml)

Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) (50 mcg/2 ml)

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 PRAStaff@fda.hhs.gov

"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."

5

Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray color.

510(k) Summary for K241909

This summary of 510(k) K241909 is being submitted in accordance with 21 CFR 807.92.

Date Summary was Prepared	September 27, 2024
510(k) Submitter	O & M Halyard, Inc.
9120 Lockwood Boulevard
Mechanicsville, VA 231161
Primary Contact for
this 510(k) Submission	Caitlin Senter, MS, RAC
Tel: 678-221-7330
Email: caitlin.senter@owens-minor.com
Marketed Device Trade Name	Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,
Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric
Acid and Fentanyl in Simulated Gastric Acid
Device Submission Trade name
and Description	Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,
Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric
Acid and Fentanyl in Simulated Gastric Acid
Device Common Name	Medical Exam Gloves
Device Product Code
and Classification Name	LZA Class I, 21 CFR §880.6250 Patient Examination Glove
LZC Class I, 21 CFR §880.6250 medical glove, specialty
OPJ Class I, 21 CFR §880.6250 Medical Gloves with Chemotherapy Labeling
Claims - Test For Use with Chemotherapy Drugs
QDO Class I, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove
Predicate Device	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)
Reference Device	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)
Subject Device Description	The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis
Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,
Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable,
9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip,
ambidextrous, non-sterile patient examination gloves.
Indications for Use	Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are 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) | |
| 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 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 | |
| | |
| The following hazardous drugs (opioids) and concentration had NO | |
| breakthrough detected up to 240 minutes: | |
| Fentanyl Citrate Injection (100 mcg/2 ml) | |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |

6

Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a light gray color. The font is sans-serif and the overall design is clean and professional.

7

Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray color. The ampersand symbol is placed between the two words.

Technological Characteristics Comparison Table
	Subject Device
(K241909)	Predicate Device
(K213929)	Reference Device
(K213937)	Comparison
FDA Product Code	LZA, LZC, OPJ, QDO	LZA, OPJ, QDO	LZA, LZC, QDO	Similar
FDA Classification	Class I	Class I	Class I	Same
Regulation Number	880.6250	880.6250	880.6250	Same
Common Name	Medical Exam Glove	Medical Exam Glove	Medical Exam Glove	Same
Device Trade Name	Halyard Purple Nitrile*
Powder-Free Exam
Gloves, Low Dermatitis
Potential, Tested for
Use with
Chemotherapy Drugs,
Fentanyl Citrate,
Simulated Gastric Acid
and Fentanyl in
Simulated Gastric Acid	Halyard Purple Nitrile,
Powder-Free Exam Gloves
Tested for Use with
Chemotherapy Drugs,
Fentanyl Citrate,
Simulated Gastric Acid
and Fentanyl in Simulated
Gastric Acid	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	Similar
Intended
Use/Indications for
Use	Halyard Purple Nitrile*
Powder-Free Exam
Gloves, Low Dermatitis
Potential, Tested for
Use with Chemotherapy
Drugs, Fentanyl Citrate,
Simulated Gastric Acid
and Fentanyl in
Simulated Gastric Acid
are disposable devices
intended for medical
purposes that are 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)	Halyard Purple Nitrile*
Powder-Free Exam Gloves,
Tested for Use with
Chemotherapy Drugs,
Fentanyl Citrate,
Simulated Gastric Acid and
Fentanyl in Simulated
Gastric Acid are disposable
devices intended for
medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner.
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	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 HCI (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	Similar
Adding Low
Dermatitis
Potential
claim to
subject
device as
compared to
reference
predicate

8

Image /page/8/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a light gray color.

9

Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon color on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a light gray color. The logo is simple and professional, and the colors are complementary.

| 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)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 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)
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 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 | 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)
Oxaliptin (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml) | 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 | Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCI (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 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

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

10

Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored emblem on the left and the company name in gray on the right. The emblem features the letters "OM" in a stylized design with horizontal lines running through the "O". The company name "Owens & Minor" is written in a serif font, with "Owens" stacked above "& Minor".

11

Image /page/11/Picture/0 description: The image is a logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a light gray color. The ampersand symbol is also in light gray.

| Technological
Characteristics | Colored, 9.5 inch,
chlorinated, nitrile,
powder-free, textured
fingertip,
ambidextrous, non-
sterile patient
examination glove | Colored, 9.5 inch,
chlorinated, nitrile,
powder-free, textured
fingertips, ambidextrous,
non-sterile patient
examination glove | Colored, 9.5 inch,
chlorinated, nitrile,
powder-free, textured
fingertip,
ambidextrous, non-
sterile patient
examination glove | Same |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL | Similar
Adding XXL
size to
subject
device |
| Color | Purple | Purple | Lavender | Similar |
| Texture | Textured fingertips | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Based on ISO 10993,
Part 11 Biological
Evaluation of Medical
Devices – Test for
systemic toxicity, the
test article was
considered non- toxic.
Meets the acceptance
criteria.
Based on ISO 10993,
Part 23- Biological
Evaluation of Medical
Devices – Test for
irritation, the test
article was considered
non-irritant. Meets the
acceptance criteria.
Based on ISO 10993,
Part 10 - Biological
Evaluation of Medical
Devices – Test for skin
sensitization, the test
article was considered a
non- sensitizer. Meets
the acceptance criteria. | Based on ISO 10993, Part 11
Biological Evaluation of
Medical devices - Test for
systemic toxicity, the test
article was considered
non-toxic. Meets the
acceptance criteria.
Based on ISO 10993, Part
10- Biological Evaluation
of Medical Devices – Test
for irritation, the test
article was considered
non- irritant. Meets the
acceptance criteria.
Based on ISO 10993, Part
10 - Biological Evaluation
of Medical Devices – Test
for skin sensitization, the
test article was
considered non-sensitizer.
Meets the acceptance
criteria. | Based on ISO 10993,
Part 11 Biological
Evaluation of Medical
Devices - Test for
systemic toxicity, the
test article was
considered non-toxic.
Meets the acceptance
criteria.
Based on ISO 10993,
Part 10- Biological
Evaluation of Medical
Devices – Test for
irritation, the test
article was considered
non-irritant. Meets the
acceptance criteria.
Based on ISO 10993,
Part 10 - Biological
Evaluation of Medical
Devices – Test for skin
sensitization, the test
article was considered
a non- sensitizer.
Meets the acceptance
criteria. | Same |

12

Image /page/12/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored emblem on the left and the company name in gray on the right. The emblem features a stylized "OM" with horizontal lines running through the "O". The company name, "Owens & Minor," is written in a serif font, with "&" connecting the two names.

Performance Data for Chemotherapy Drugs
Standard	Subject Device
(K241909)	Predicate Device
(K213929)	Reference Device
(K213937)	Remarks
ASTM D6978-05
Standard Practice for
Assessment of
Resistance of Medical
Gloves to Permeation
by Chemotherapy
Drugs	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)	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)	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)	Similar

13

Image /page/13/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored emblem on the left and the company name in gray on the right. The emblem features the letters "OM" with horizontal lines running through them. The company name, "Owens & Minor," is written in a serif font, with the "&" symbol connecting the two names.

Fludarabine (25 mg/ml)	Irinotecan HCl (20 mg/ml)	Fludarabine (25 mg/ml)
5-Fluorouracil (50
mg/ml)	Leuprolide Acetate Salt (5
mg/ml)	5-Fluorouracil (50
mg/ml)
Fulvestrant (50 mg/ml)	Mechlorethamine HCl (1
mg/ml)	Fulvestrant (50 mg/ml)
Gemcitabine (38
mg/ml)	Melphalan (5 mg/ml)	Gemcitabine (38
mg/ml)
Idarubicin (1 mg/ml)	Methotrexate (25 mg/ml)	Idarubicin (1 mg/ml)
Ifosfamide (50 mg/ml)	Mitomycin C (0.5 mg/ml)	Ifosfamide (50 mg/ml)
Irinotecan HCl (20
mg/ml)	Mitoxantrone (2 mg/ml)	Irinotecan HCl (20
mg/ml)
Leuprolide Acetate Salt
(5 mg/ml)	Oxaliplatin (5 mg/ml)	Leuprolide Acetate Salt
(5 mg/ml)
Mechlorethamine HCl
(1 mg/ml)	Paclitaxel (6 mg/ml)	Mechlorethamine HCl
(1 mg/ml)
Melphalan (5 mg/ml)	Pemetrexed (25 mg/ml)	Melphalan (5 mg/ml)
Methotrexate (25
mg/ml)	Raltitrexed (0.5 mg/ml)	Methotrexate (25
mg/ml)
Mitomycin C (0.5
mg/ml)	Retrovir (10 mg/ml)	Mitomycin C (0.5
mg/ml)
Mitoxantrone (2
mg/ml)	Rituximab (10 mg/ml)	Mitoxantrone (2
mg/ml)
Oxaliplatin (5 mg/ml)	Temsirolimus (25 mg/ml)	Oxaliplatin (5 mg/ml)
Paclitaxel (6 mg/ml)	Topotecan HCl (1 mg/ml)	Pemetrexed (25
mg/ml)
Pemetrexed (25
mg/ml)	Triclosan (2 mg/ml)	Paclitaxel (6 mg/ml)
Raltitrexed (0.5 mg/ml)	Trisenox (1 mg/ml)	Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)	Vinblastine Sulfate (1
mg/ml)	Retrovir (10 mg/ml)
Rituximab (10 mg/ml)	Vincristine (1 mg/ml)	Rituximab (10 mg/ml)
Temsirolimus (25
mg/ml)	Vinorelbine (10 mg/ml)	Temsirolimus (25
mg/ml)
Topotecan HCl (1
mg/ml)	Zoledronic Acid (0.8
mg/ml)	Topotecan HCl (1
mg/ml)
Triclosan (2 mg/ml)	The following
chemotherapy drugs and
concentration showed
breakthrough detected in
less than 90 minutes:	Triclosan (2 mg/ml)
Trisenox (1 mg/ml)	Carmustine (3.3 mg/ml)
No breakthrough up to	Trisenox (1 mg/ml)
Vinblastine Sulfate (1
mg/ml)	55.3 minutes.
Thiotepa (10 mg/ml) No
breakthrough up to 78.8
minutes.	Vinblastine Sulfate (1
mg/ml)
Vincristine (1 mg/ml)	Warning- Not for use with
Carmustine and ThioTEPA	Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)		Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8
mg/ml)	The following	Zoledronic Acid (0.8
mg/ml)
The following		chemotherapy drugs
chemotherapy drugs		and concentration
and concentration		showed
showed breakthrough		breakthrough detected
detected in less than		in less than
90 minutes:		60 minutes:
Carmustine (3.3
mg/ml) No		Carmustine (3.3
mg/ml) No
breakthrough up to		breakthrough up to 0.3

14

Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a light gray color. The letters "OM" have horizontal lines going through them.

		Performance Data for Hazardous Drugs (opioids)
	55.3 minutes.
Thiotepa (10 mg/ml)
No breakthrough up to
78.8 minutes.
Warning- Not for use
with Carmustine and
ThioTEPA		minutes.
Thiotepa (10 mg/ml)
No
breakthrough up to
30.9 minutes.
Warning: Not for Use
With:
Carmustine, Thiotepa
ASTM D6978-05
Standard Practice for
Assessment of
Resistance of Medical
Gloves to Permeation
by Chemotherapy
Drugs	The following
hazardous drugs
(opioids) and
concentration had
NO breakthrough
detected up to 240
minutes:
Fentanyl Citrate
Injection (100 mcg/2
ml)
Simulated Gastric
Acid Fluid/Fentanyl
Citrate Injection Mix
50/50 Solution	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	The following
hazardous drugs
(opioids) and
concentration had NO
breakthrough detected
up to 240
minutes:
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	Same

Performance Data
ASTM D5151-06
Standard Test Method
for Detection of Holes
in Medical Gloves	Testing of the subject
device shows it meets
the 2.5% AQL
requirement in the
standards for
leakage. The device
meets the
acceptance criteria of
the standard.	Testing of the predicate
device shows it meets the
2.5% AQL requirement in
the standards for leakage.
The device meets the
acceptance criteria of the
standard.	Testing of the
reference device
shows it meets the
2.5% AQL requirement
in the standards for
leakage. The device
meets the acceptance
criteria of the
standard.	Same
ASTM D6124-06
Standard Test
Method for Residual
Powder on Medical
Gloves	Residual powder on
the subject device is
an average of 0.4
mg/glove within the
powder-free limit of