Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

K183132 · O&M Halyard, Inc. · LZC · Feb 5, 2019 · General Hospital

Device Facts

• Record ID: K183132
• Device Name: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
• Applicant: O&M Halyard, Inc.
• Product Code: LZC · General Hospital
• Decision Date: Feb 5, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Halyard Pink Underguard Nitrile Powder-Free Exam Glove is a disposable device 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 Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatin (10 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (2 mg/ml) No breakthrough up to 240 minutes Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes. CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes.

Device Story

Disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove; packed in cardboard dispenser box. Used by clinicians to prevent cross-contamination during patient examinations. Provides barrier protection against specific chemotherapy drugs; permeation resistance tested per ASTM D6978-05. Healthcare providers use gloves as standard personal protective equipment; output is physical barrier protection. Benefits include reduced risk of contamination and exposure to hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. Performance evaluated via ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (leakage), ASTM D6319-10 (physical dimensions/properties), and ASTM D6124-06 (residual powder). Biocompatibility testing included ISO 10993-11 (systemic toxicity), ISO 10993-10 (dermal irritation/sensitization). Results demonstrate compliance with standards and equivalence to predicate.

Technological Characteristics

Material: Nitrile; powder-free; chlorinated. Form factor: 12-inch length, 0.09 mm palm thickness, textured fingertip, ambidextrous. Non-sterile. Standards: ASTM D6978-05, ASTM D5151-06, ASTM D6319-10, ASTM D6124-06, ISO 10993-10/11.

Indications for Use

Indicated for medical purposes as a disposable glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by 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 Sterling Nitrile-Xtra Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs (K081089)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 5, 2019

0 & M Halyard, Inc. Angela Bunn Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004

Re: K183132

Trade/Device Name: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 8, 2018 Received: November 13, 2018

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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known) K183132

#### Device Name

Halyard Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

The Halyard Pink Underguard Nittile Powder-Free Exam Glove is a disposable device 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
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- · Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- · Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes

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- · Rituximab (10 mg/ml) No breakthrough up to 240 minutes
- · Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
- Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
- · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
- · Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
- Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
- · Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
- · Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes

CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:

- Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
- · ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary (K183132)

| Date Summary was<br>Prepared | January 31,2019 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Angela L. Bunn, RAC<br>Director Regulatory Affairs<br>Tel: [phone]<br>Email: [e-mail] |
| Primary Contact for this<br>510(k) Submission | Same as above |
| Device Trade Name | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs |
| Device Common Name | Non-Powdered Patient Examination Glove |
| Device Product Code and<br>Classification Name | LZA, LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove |
| Predicate Device | K081089<br>Halyard Sterling Nitrile-Xtra Powder-Free Exam Gloves Tested for Use with<br>Chemotherapy Drugs |
| Subject Device Description | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile,<br>powder-free, textured fingertip, ambidextrous, non- sterile patient examination<br>gloves that are packed in a cardboard dispenser box. |
| Indications for Use | The Halyard® Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use<br>with Chemotherapy Drugs is a disposable device intended for medical purposes<br>that is worn on the examiner's hand to prevent contamination between patient and<br>examiner. These gloves were tested for use with the following chemotherapy<br>drugs:<br>● Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes<br>● Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes<br>● Bendamustine (5 mg/ml) No breakthrough up to 240 minutes<br>● Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes<br>● Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes<br>● Busulfan (6 mg/ml) No breakthrough up to 240 minutes<br>● Carboplatin (10 mg/ml) No breakthrough up to 240 minutes |

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| Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes<br>●<br>Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes<br>●<br>Cisplatin (1 mg/ml) No breakthrough up to 240 minutes<br>Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes<br>●<br>Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes<br>Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes<br>Cytovene (10 mg/ml) No breakthrough up to 240 minutes<br>●<br>Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes<br>Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes<br>Decitabine (5 mg/ml) No breakthrough up to 240 minutes<br>Docetaxel (10 mg/ml) No breakthrough up to 240 minutes<br>Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes<br>●<br>Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes<br>Etoposide (20 mg/ml) No breakthrough up to 240 minutes<br>●<br>Fludarabine (25 mg/ml) No breakthrough up to 240 minutes<br>●<br>Fluorouracil (50 mq/ml) No breakthrough up to 240 minutes<br>Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes<br>●<br>Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes<br>●<br>ldarubicin (1 mq/ml) No breakthrough up to 240 minutes<br>lfosfamide (50 mq/ml) No breakthrough up to 240 minutes<br>Irinotecan (20 mg/ml) No breakthrough up to 240 minutes<br>Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes<br>Melphalan (5 mg/ml) No breakthrough up to 240 minutes<br>Methotrexate (25 mg/ml) No breakthrough up to 240 minutes<br>Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes<br>Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes<br>Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes<br>Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes<br>Paraplatin (10 mg/ml) No breakthrough up to 240 minutes<br>Pemetrexed (25 mq/ml) No breakthrough up to 240 minutes<br>●<br>Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes<br>Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes<br>Retrovir (10 mg/ml) No breakthrough up to 240 minutes<br>Rituximab (10 mg/ml) No breakthrough up to 240 minutes<br>Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes<br>Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes<br>Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes<br>●<br>Triclosan (2 mg/ml) No breakthrough up to 240 minutes<br>Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes<br>●<br>Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes<br>● |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vinblastine (1 mg/ml) No breakthrough up to 240 minutes<br>●<br>Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes<br>●<br>Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes<br>●<br>Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes<br>ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes |

| Technological Characteristic Comparison Table | | | |
|-----------------------------------------------|-------------------------------------------|-------------------------------------------|------------|
| | Subject Device:<br>K183132 | Predicate Device:<br>K081089 | Comparison |
| FDA Product<br>Code | LZA, LZC | LZC | Same |
| FDA<br>Classification | Class I | Class I | Same |
| Common Name | Non-Powdered<br>Patient Examination Glove | Non-Powdered<br>Patient Examination Glove | Same |

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| Device Trade<br>Name | Halyard Pink Underguard Nitrile<br>Powder-Free Exam Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Halyard Sterling Nitrile Xtra<br>Powder-Free Exam Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Similar |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for<br>Use | The Halyard Pink Underguard<br>Nitrile Powder-Free Nitrile<br>Exam Glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. These gloves<br>were tested for use with<br>chemotherapy drugs listed on<br>the label. | The Halyard Sterling Nitrile-Xtra<br>Powder-Free Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. These gloves were<br>tested for use with chemotherapy<br>drugs listed on the label. | Same |
| Technological<br>Characteristics | Pink-colored, 12-inch, 0.09<br>mm thick at palm, nitrile,<br>powder-free, textured<br>fingertip, ambidextrous, non-<br>sterile patient examination<br>glove. | Gray-colored, 12-inch, 0.90 mm<br>thick at palm, nitrile, powder-free,<br>textured fingertip, ambidextrous,<br>non- sterile patient examination<br>glove. | Similar |

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| Technological Charateristic Comparison Table | | | |
|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Standard | Subject Device:<br>K183132 | Predicate Device:<br>K081089 | Comparison |
| TM D6978-05<br>Standard Practice for<br>Assessment of<br>Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | No signs of breakthrough after 4 hours for 50<br>drugs.<br>Result: Meets acceptance criteria.<br>No breakthrough up to 240 minutes:<br>Arsenic Trioxide (1 mg/ml)<br>Azacitidine (Vidaza) (25 mg/ml)<br>Bendamustine (5 mg/ml)<br>Bortezomib (Velcade) (1 mg/ml)<br>Bleomycin sulfate (15 mg/ml)<br>Busulfan (6 mg/ml)<br>Carboplatin (10 mg/ml)<br>Carfilzomib (2 mg/ml)<br>Cetuximab (Erbitux) (2 mg/ml)<br>Cisplatin (1 mg/ml)<br>Cladribine (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Cytarabine HCL (100 mg/ml)<br>Cytovene (10 mg/ml)<br>Dacarbazine (10 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>Ellence (2 mg/ml)<br>Etoposide (20 mg/ml)<br>Fludarabine (25 mg/ml)<br>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 (20 mg/ml)<br>Mechlorethamine HCL (1 mg/ml)<br>Melphalan (5 mg/ml)<br>Methotrexate (25 mg/ml)<br>Mitomycin (0.5 mg/ml)<br>Mitoxantrone (2 mg/ml)<br>Oxaliplatin (2 mg/ml)<br>Paclitaxel (6 mg/ml)<br>Paraplatin (10 mg/ml)<br>Pemetrexed (25 mg/ml)<br>Pertuzumab (30 mg/ml)<br>Raltitrexed (0.5 mg/ml)<br>Retrovir (10 mg/ml)<br>Rituximab (10 mg/ml)<br>Temsirolimus (25 mg/ml)<br>Trastuzumab (21 mg/ml)<br>Topotecan HCL (1 mg/ml)<br>Triclosan (2 mg/ml)<br>Trisonex (1.0 mg/ml)<br>Vincrinstine Sulfate (1 mg/ml)<br>Vinblastine (1 mg/ml)<br>Vinorelbine (10 mg/ml)<br>Zoledronic Acid (0.8 mg/ml)<br>Carmustine (3.3 mg/ml) No breakthrough up to<br>54.7 minutes<br>ThioTEPA (10 mg/ml) No breakthrough up to<br>128.5 minutes | No signs of breakthrough after 4<br>hours for 10 drugs.<br>Result: Meets acceptance criteria.<br>No breakthrough up to 240<br>minutes: Cisplatin (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Dacarbazine (10 mg/ml)<br>Doxorubicin HCL (2 mg/ml)<br>Etoposide (20 mg/ml)<br>Fluorouracil (50 mg/ml)<br>Ifosfamide (50 mg/ml)<br>Mitoxantrone (2 mg/ml)<br>Paclitaxel (6 mg/ml)<br>Vincrinstine Sulfate (1<br>mg/ml)<br>Carmustine (3.3 mg/ml)<br>Not for Use with Carmustine ThioTEPA<br>(10.0 mg/ml)<br>Not for Use with ThioTEPA | Similar with different<br>breakthrough times for<br>Carmustine and ThioTEPA. |

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| Summary of<br>Technological<br>Characteristic<br>Comparison | There are no different technological characteristics of the subject device compared to the predicate<br>device. They are powder-free non-sterile nitrile exam gloves tested for resistance to permeation by<br>chemotherapy drugs. The subject device was tested for use with 52 drugs and the predicate device was<br>tested for use with 12 drugs. The color is different between the subject device and the predicate. |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Summary of Non-Clinical Performance Data | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--|--|
| Test Method | Subject Device:<br>K183132 | Test Method | Predicate Device:<br>K081089 | Comparison | | |
| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>Gloves | Testing of the subject device<br>shows it meets the 2.5% AQL<br>requirement in the standards<br>for leakage. The device meets<br>the acceptance criteria of the<br>standard. | ASTM D5151-06<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | Testing of the predicate<br>device shows it meets the<br>2.5% AQL requirement in<br>the standards for leakage.<br>The device meets the<br>acceptance criteria of the<br>standard. | Same | | |
| ASTM D6319-10<br>Standard<br>Specification for<br>Nitrile<br>Examination<br>Gloves for<br>Medical<br>Applications | The physical dimensions of the<br>subject device are within the<br>limits of the standard and the<br>physical properties of the<br>subject device meet the<br>requirements for tensile<br>strength with an average before<br>aging of 37.89 MPa and after<br>aging of 39.32 MPa and<br>elongation of 602% before<br>aging and 558% after aging. | ASTM D6319-10<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Applications | The physical dimensions<br>of the predicate device<br>are within the limits of the<br>standard and the<br>physical properties of the<br>subject device meet the<br>requirements for tensile<br>strength with a target<br>after aging of 38 MPa<br>and elongation of 550%<br>after aging. | Similar | | |
| ASTM D6124-06<br>Standard Test<br>Method for<br>Residual<br>Powder on<br>Medical Gloves | Residual powder on the<br>subject device is an average<br>of 0.4 mg/glove within the<br>powder-free limit of < 2 mg<br>maximum powder per glove<br>and meets the acceptance<br>criteria for powder- free. | ASTM D6124-06<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | Residual powder on the<br>predicate device is an<br>average of 0.4 mg/glove<br>within the powder-free<br>limit of < 2 mg maximum<br>powder per glove and<br>meets the acceptance<br>criteria for powder- free. | Same | | |
| 10993-11: 2017 Biological evaluation of medical devices - Tests for systemic toxicity. | | | | | | |
| Systemic Toxicity -<br>ISO Systemic<br>Injection Test in<br>Mice – Sodium<br>Chloride (NaCI)<br>and Cottonseed Oil<br>(CSO) extracts | No mortality or evidence of<br>systemic toxicity from the<br>extracts. | Systemic Toxicity -<br>ISO Systemic Injection<br>Test in Mice - Sodium<br>Chloride (SC) and<br>Sesame Oil (SO) extracts | No mortality or evidence of<br>systemic<br>toxicity<br>from<br>the extracts. | The device<br>extracts did not<br>elicit systemic<br>responses | | |
| 10993-10: 2010 Biological evaluation of medical devices – Tests for irritation and skin sensitization. | | | | | | |

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| Dermal Irritation -<br>ISO Indirect<br>Primary Skin<br>Irritation Test in<br>Rabbits - 0.9%<br>Sodium Chloride<br>(NaCl) for Injection<br>and Cottonseed Oil<br>(CSO) extracts | Based on the criteria/conditions of<br>the study, the test article<br>extracts were<br>considered<br>non-irritating. | Dermal Irritation- ISO<br>Skin Irritation Study-<br>Topical article application | Based on the criteria/<br>conditions of the study, the<br>test article extracts were<br>considered non-irritating. | The device<br>extracts are not<br>irritants. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Dermal<br>Sensitization-<br>ISO Kligman<br>Maximization Test<br>- NaCl and CSO<br>extracts | The test article extracts<br>showed no evidence of<br>causing delayed dermal<br>contact<br>sensitization. | ISO Local Lymph Node<br>Assay (LLNA) (NaCl and<br>DMSO extracts) | The test article extracts<br>showed no evidence<br>of causing delayed<br>dermal contact<br>sensitization. | The device<br>extracts are not<br>sensitizers |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as<br>well as or better than the legally marketed device, K081089 | | | |