(228 days)
The Halyard Purple Nitrile, Powder-Free Exam Gloves 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 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
No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The Halyard Purple Powder-Free Nitrile Exam Glove tested with Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and are packed in a cardboard dispenser box.
The document describes the acceptance criteria and performance data for Halyard Purple Nitrile, Powder-Free Exam Gloves, which are medical gloves, not an AI-powered device. Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, sample size for training set, ground truth for training set) are not applicable to this submission.
The information provided pertains to the physical and chemical performance of the gloves when exposed to certain substances.
Here's a breakdown of the applicable information from the provided document, restructured to address the closest relevant aspects of your request:
1. A table of acceptance criteria and the reported device performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319 | Length: 230 – 258 mm; Palm Width Size: 85 – 105 mm; Finger thickness: 0.05-0.09 mm; Palm thickness: 0.05-0.09 mm | Meets requirements |
| Physical Properties (Tensile Strength) | ASTM D6319 | Before aging: ≥14 MPa (Tensile Strength), ≥500% (Ultimate elongation); After aging: ≥14 MPa (Tensile Strength), ≥400% (Ultimate elongation) | Meets requirements |
| Freedom from Pinholes (Leakage) | ASTM D6319, ASTM D5151 | AQL 2.5%, No leakage | Meets requirements (Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage.) |
| Powder Free | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove (maximum powder) | Meets requirements (Average of 0.4 mg/glove, within the powder-free limit) |
| ISO Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Device is not an irritant under the study conditions. |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity. |
| ISO Dermal 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.