Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

K182096 · Owens & Minor Halyard, Inc. · LZA · Nov 2, 2018 · General Hospital

Device Facts

Record IDK182096
Device NameHalyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
ApplicantOwens & Minor Halyard, Inc.
Product CodeLZA · General Hospital
Decision DateNov 2, 2018
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 880.6250
Device ClassClass 1

Intended Use

The Halyard Purple Nitrile Max Powder-Free Nitrile 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 Carlzomib (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 ThioTEPA (10 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 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 Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes

Device Story

Disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove. Used in clinical settings by healthcare providers to prevent contamination. Provides barrier protection against patient fluids and specific chemotherapy drugs. Subject device features 16-inch length and 0.24 mm palm thickness.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM D5151-06 (leakage), ASTM D6319-10 (physical properties), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity) confirmed safety.

Technological Characteristics

Material: Nitrile. Form: 16-inch length, 0.24 mm palm thickness, textured fingertip, powder-free, chlorinated, non-sterile. Standards: ASTM D5151-06, ASTM D6319-10, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner. Tested for resistance to 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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 2, 2018 Owens & Minor Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004 Re: K182096 Trade/Device Name: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: August 2, 2018 Received: August 3, 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known) K182096 #### Device Name Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs #### Indications for Use (Describe) The Halyard Purple Nitrile Max Powder-Free Nitrile 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 - Carlzomib (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 {3}------------------------------------------------ | • 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 | | • ThioTEPA (10 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 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 | | | Carmustine (3.3 mg/ml) | permeation occurred at 128.5 minutes | Type of Use (Select one or both, as applicable) | <div style="display:inline-block;"><input type="checkbox"/></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"><input checked="" type="checkbox"/></div> 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." {4}------------------------------------------------ ## K182096 510(k) Summary | Date Summary<br>was Prepared | November 1, 2018 | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Owens & Minor Halyard, Inc.<br>5405 Windward Parkway<br>Alpharetta, GA 30004 USA | | Primary Contact for<br>this Submission | Angela L. Bunn, RAC<br>Director Regulatory Affairs<br>Tel: 470-448-5856<br>Email: angela.bunn@hyh.com | | Device Trade Name | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with<br>Chemotherapy Drugs | | Device Common Name | Patient Examination Glove | | Device Product Code<br>and Classification Name | LZC<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove | | Predicate Device | K160709<br>Halyard Purple Nitrile-Xtra Powder-Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs | | Subject Device Description | Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs are disposable, purple-colored, chlorinated,<br>nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient<br>examination gloves that are packed in a cardboard dispenser box | {5}------------------------------------------------ | Indications for Use | The Halyard Purple Nitrile Max Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs 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:<br>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 Carlzomib (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 ThioTEPA (10 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 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 Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {6}------------------------------------------------ | Technological Characteristic<br>Comparison Table | Subject Device<br>Purple-colored, 16 inch, 0.24 mm<br>thick at palm, nitrile, powder-free,<br>textured fingertip, ambidextrous,<br>non- sterile patient examination<br>glove. | Predicate K160709<br>Purple-colored, 12 inch, 0.11 mm thick<br>at palm, nitrile, powder-free, textured<br>fingertip, ambidextrous, non- sterile<br>patient examination glove. | | |--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | | Subject Device K182096 | Predicate Device K160709 | Comparison | | FDA Product<br>Code | LZC | LZC | Same | | FDA<br>Classification | Class I | Class I | Same | | Common Name | Patient Exam Glove | Patient Exam Glove | Same | | Device Trade<br>Name | Halyard Purple Nitrile Max Powder-<br>Free Exam Gloves Tested for Use<br>with Chemotherapy Drugs | Halyard Purple Nitrile Xtra<br>Powder-Free Exam Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Similar | | Intended Use | The Halyard Purple Nitrile Max<br>Powder-Free Nitrile Exam Glove is<br>a disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient and<br>examiner. These gloves were<br>tested for use with chemotherapy<br>drugs listed in the IFU statement. | The Halyard Purple 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 in the IFU statement. | Same | | Technological<br>Characteristics | Purple-colored, 16 inch, 0.24 mm<br>thick at palm, nitrile, powder-free,<br>textured fingertip, ambidextrous,<br>non- sterile patient examination<br>glove. | Purple-colored, 12 inch, 0.11 mm<br>thick at palm, nitrile, powder-free,<br>textured fingertip, ambidextrous,<br>non- sterile patient examination<br>glove. | Similar | | Performance Data | | | | | Standard | Results<br>Subject Device | Results<br>K160709 | Remarks | | ASTM D6978-05 | No signs of breakthrough after 4 | No signs of breakthrough after 4 | Similar with different | | | hours for 51 drugs. | hours for 51 drugs. | breakthrough times | | Standard | Carmustine showed no signs of | Carmustine showed no signs of | for Carmustine. | | Practice for | breakthrough until 128.5 minutes | breakthrough until 80.4 minutes | | | Assessment of<br>Resistance of | Result: Meets acceptance criteria. | Result: Meets acceptance criteria. | | | Medical Gloves | No breakthrough up to 240 | No breakthrough up to 240 | | | to Permeation | minutes: | minutes: | | | by | Arsenic Trioxide (1 mg/ml) | Arsenic Trioxide (1 mg/ml) | | | Chemotherapy | Azacitidine (Vidaza) (25 mg/ml) | Azacitidine (Vidaza) (25 mg/ml) | | | Drugs | Bendamustine (5 mg/ml) | Bendamustine (5 mg/ml) | | | | Bortezomib (Velcade) (1 mg/ml) | Bortezomib (Velcade) (1 mg/ml) | | | | Bleomycin sulfate (15 mg/ml) | Bleomycin sulfate (15 mg/ml) | | | | Busulfan (6 mg/ml) | Busulfan (6 mg/ml) | | | | Carboplatin (10 mg/ml) | Carboplatin (10 mg/ml) | | | | Carfilzomib (2 mg/ml) | Carfilzomib (2 mg/ml) | | | | Cetuximab (Erbitux) (2 mg/ml) | Cetuximab (Erbitux) (2 mg/ml) | | | | Cisplatin (1 mg/ml)<br>Cladribine (1 mg/ml) | Cisplatin (1 mg/ml) | | | | Cyclophosphamide (20 mg/ml) | Cyclophosphamide (20 mg/ml)<br>Cytarabine HCL (100 mg/ml) | | | | Cytarabine HCL (100 mg/ml) | Cytovene (10 mg/ml) | | | | Cytovene (10 mg/ml) | Dacarbazine (10 mg/ml) | | | | Dacarbazine (10 mg/ml) | Daunorubicin HCL (5 mg/ml)…
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