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A patient examination 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 chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: The following drugs and concentration had NO breakthrough detected up to 240 minutes: - Bendamustine HCl (5 mg/mL) - Bleomycin Sulfate (15 mg/mL) - Busulfan (6 mg/mL) - Carboplatin (10 mg/mL) - Carfilzomib (2 mg/mL) - Cetuximab (Erbitux) (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 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) - Epirubicin HCl (2 mg/mL) - Etoposide (20 mg/mL) - Fludarabine Phosphate (25 mg/mL) - Fluorouracil (50 mg/mL) - Fulvestrant (50 mg/mL) - Gemcitabine HCl (38 mg/mL) - Idarubicin HCl (1 mg/mL) - Ifosfamide (50 mg/mL) - Irinotecan HCl (20 mg/mL) - Mechlorethamine HCl (1 mg/mL) - Melphalan HCl (5 mg/mL) - MESNA (100 mg/mL) - Methotrexate (25 mg/mL) - Mitomycin C (0.5 mg/mL) - Mitoxantrone HCl (2 mg/mL) - Oxaliplatin (2 mg/mL) - Paclitaxel (6 mg/mL) - Pemetrexed (25 mg/mL) - Propofol (10 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 (1 mg/mL) - Trisenox (Arsenic Trioxide) (1 mg/mL) - Velcade (Bortezomib) (1 mg/mL) - Vidaza (Azacitidine) (25 mg/mL) - Vinblastine Sulfate (1 mg/mL) - Vincristine Sulfate (1 mg/mL) - Vinorelbine Tartrate (10 mg/mL) - Zoledronic Acid (0.8 mg/mL) The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: - Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes - Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes Warning: Not recommended for use with Carmustine and Thiotepa The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: - Fentanyl Citrate Injection (100mcg/2mL) - Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state. The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.

A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES