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The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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) - Carfilzomib (2 mg/ml) - Cetuximab (2 mg/ml) - Cisplatin (1 mg/ml) - Cladribine (1 mg/ml) - Cyclophosphamide (20 mg/ml) - Cytarabine HCl (100 mg/ml) - Dacarbazine (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 (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) - Leuprolide Acetate (5 mg/ml) - Mechlorethamine HCl (1 mg/ml) - Melphalan HCl (5 mg/ml) - Methotrexate (25 mg/ml) - Mitomycin C (0.5 mg/ml) - Mitoxantrone HCl (2 mg/ml) - Oxaliplatin (5 mg/ml) - Paclitaxel (6 mg/ml) - Pemetrexed (25 mg/ml) - Raltitrexed (0.5 mg/ml) - Rituximab (10 mg/ml) - Temsirolimus (25 mg/ml) - Topotecan HCl (1 mg/ml) - Trisenox (Arsenic Trioxide) (1 mg/ml) - Vinblastine Sulfate (1 mg/ml) - Vincristine (1 mg/ml) - Vinorelbine Tartrate (10 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes: - Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes. - Thiotepa (10 mg/ml) No breakthrough up to 99.1 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 hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: - Chloroquine (50 mg/ml) - Cyclosporin A (100 mg/ml) - Cytovene (10 mg/ml) - Retrovir (10 mg/ml) - Triclosan (2 mg/ml) - Zoledronic Acid (0.8 mg/ml)

The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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, sterile patient examination gloves.

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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes | |---|---|---| | *Carmustine | 3.3mg/ml | 22.5 | | Cisplatin | 1 mg/ml | >240 | | Cyclophosphamide | 20 mg/ml | >240 | | Dacarbazine | 10 mg/ml | >240 | | Doxorubicin, HCl | 2 mg/ml | >240 | | Etoposide | 20 mg/ml | >240 | | Fluorouracil | 50 mg/ml | >240 | | Methotrexate | 25 mg/ml | >240 | | Mitomycin | 0.5 mg/ml | >240 | | Oxaliplatin | 5 mg/ml | >240 | | Paclitaxel | 6 mg/ml | >240 | | *Thiotepa | 10 mg/ml | 34.5 | | Vincristine | 1 mg/ml | >240 | | Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes | |---|---|---| | Fentanyl Citrate Injection | 100mcg/2ml | >240 | **Warning:** Do not use with Carmustine and Thiotepa. ***Note:*** Please note that the following drugs have low permeation times: (1) Carmustine - 22.5 minutes (2) Thiotepa - 34.5 minutes.

The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves. The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.

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 and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex. GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.

An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.