(88 days)
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, 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 are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :
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) Carlzomib (2 mg/ml) Cetuximab (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 (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (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 (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 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 (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 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) (50 mcg/2 ml)
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, 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, non-sterile patient examination gloves.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mm | Meets requirements |
| Palm Width: XS: 60-80mm, S: 70-90mm, M: 85-105mm, L: 100-120mm, XL: 110-130mm, XXL: 120-140mm | Meets requirements | ||
| Finger, Palm, Cuff thickness ≥0.05 mm | Meets requirements | ||
| Physical Properties | ASTM D 6319 | AQL 4.0 | Meets requirements |
| Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500% | Meets requirements | ||
| After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements | ||
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | AQL 2.5%, No leakage | Meets requirements |
| Powder Free | ASTM D 6124, ASTM D 6319 | ≤ 2 mg / glove | Meets requirements (average of 0.4 mg/glove) |
| Test for irritation | ISO 10993, Part 23 | Grade 1 | Under the conditions of the study, the device is not an irritant. |
| Test for acute systemic toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Under the conditions of the study, no evidence of acute systemic toxicity. |
| Test for skin sensitization | ISO 10993, Part 10 | Grade |
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.