(119 days)
The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentany1 Citrate are disposable devices 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 and Fentanyl Citrate 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 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml)
Warning: Not for Use With: Carmustine, ThioTEPA
Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Regulatory Class: Class I (Non-Powdered Patient Examination Glove, Specialty; Fentanyl and other opioid protection glove)
Study Design Overview:
This appears to be a non-clinical performance study focusing on the physical characteristics and chemical permeation resistance of the gloves. It is a comparative study against a previously cleared predicate device (Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs). The primary method used for evaluating chemical permeation was ASTM D6978-05.
1. Table of Acceptance Criteria & Reported Device Performance
| Test/Characteristic | Standard | Acceptance Criteria | Reported Device Performance and Remarks |
|---|---|---|---|
| Chemical Permeation | ASTM D6978-05 | No breakthrough detected for up to 240 minutes for listed drugs. | Chemotherapy Drugs (NO Breakthrough 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) |
| **Chemotherapy Drugs (Breakthrough |
§ 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.