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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
• · 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

Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non- sterile patient examination gloves that are packed in a cardboard dispenser box.

The device described is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No breakthrough up to 240 minutes for 50 chemotherapy drugs:
  Arsenic Trioxide (1 mg/ml), Azacitidine (Vidaza) (25 mg/ml), Bendamustine (5 mg/ml), Bortezomib (Velcade) (1 mg/ml), Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Carfilzomib (2 mg/ml), Cetuximab (Erbitux) (2 mg/ml), Cisplatin (1 mg/ml), Cladribine (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCL (100 mg/ml), Cytovene (10 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCL (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCL (2 mg/ml), Ellence (2 mg/ml), Etoposide (20 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan (20 mg/ml), Mechlorethamine HCL (1 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin (0.5 mg/ml), Mitoxantrone (2 mg/ml), Oxaliplatin (2 mg/ml), Paclitaxel (6 mg/ml), Paraplatin (10 mg/ml), Pemetrexed (25 mg/ml), Pertuzumab (30 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Trastuzumab (21 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1.0 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml).
• Limited breakthrough times for specific drugs:
  Carmustine (3.3 mg/ml): No breakthrough up to 54.7 minutes
  ThioTEPA (10 mg/ml): No breakthrough up to 128.5 minutes |
  | ASTM D5151-06
  Standard Test Method for Detection of Holes in Medical Gloves | 2.5% AQL (Acceptable Quality Limit) for leakage. | Meets the 2.5% AQL requirement for leakage. |
  | ASTM D6319-10
  Standard Specification for Nitrile Examination Gloves for Medical Applications | Within limits for physical dimensions; meet requirements for tensile strength and elongation. (Specific numerical criteria for tensile strength and elongation are implied by the standard but not fully detailed in the provided text for acceptance, only for performance. For the predicate, 38 MPa tensile strength after aging and 550% elongation after aging are mentioned as targets). | Physical dimensions are within the limits of the standard.
  Physical Properties:
• Tensile Strength: Average 37.89 MPa before aging, 39.32 MPa after aging.
• Elongation: 602% before aging, 558% after aging. |
  | ASTM D6124-06
  Standard Test Method for Residual Powder on Medical Gloves | Powder-free limit of

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