(215 days)
The Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following drugs showed not breakthrough at 240 minutes: Fentanyl Citrate, 100 mcg/2ml.
The Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and 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. The following drugs showed not breakthrough at 240 minutes: Bleomycin (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (DTIC) (10.0 mg/ml) Daunorubicin (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin Hydrochloride (2.0 mg/ml) Ellence (2.0 mg/ml) Etoposide (Toposar) (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (Gemzar) (38.0 mg/ml) Idarubicin (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HC1 (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2.0 mg/ml) Paclitaxel (Taxol) (6.0 mg/ml) Paraplatin (10.0 mg/ml) Rituximab (10.0 mg/ml) Trisonex (1.0 mg/ml) Vincrinstine (1mg/ml) Fentanyl Citrate, 100 mcg/2ml. The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml) 1.8 minutes and ThioTEPA (10.0mg/ml): 1.7 minutes. Warning- Not for use with Carmustine and ThioTEPA.
The Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is a disposable, blackcolored on the grip side and orange colored on the donning side, 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 Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are chlorinated on the donning side and are packed in a cardboard dispenser box.
This document is a 510(k) premarket notification for medical gloves. It describes the acceptance criteria and performance data for two devices:
- Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate
- Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate
The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove an AI model's performance. Therefore, many of the requested items related to AI/MRMC studies, expert adjudication, and ground truth establishment for AI models are not applicable to this document.
However, I can extract the acceptance criteria and device performance as reported for these specific medical devices based on the provided text.
Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves. The performance data presented demonstrates that the subject devices meet these standards and are substantially equivalent to their predicate devices.
Device 1: Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate
| Performance Metric | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993) | ||
| Irritation (ISO 10993-10) | No erythema/edema up to 72 hours post exposure | Erythema/edema was negligible. Meets acceptance criteria. (PASS) |
| Skin Sensitization (ISO 10993-10) | No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection | Not a sensitizer under conditions of the study. Meets acceptance criteria. (PASS) |
| Systemic Toxicity (ISO 10993-11) | No signs of systemic toxicity up to 72 hours post injection | No systemic toxicity observed. Meets acceptance criteria. (PASS) |
| Physical Properties (ASTM D6319-10) | ||
| Holes (AQL) | AQL 2.5% | AQL 1.0%. Meets the 2.5 AQL requirement for leakage. (PASS) |
| Length | >230mm | 230-258mm |
| Width | 85-105mm | 85-105mm |
| Palm Thickness | >.050mm | .05-.07mm |
| Unaged Tensile Strength | >14MPa | >16MPa |
| Unaged Elongation | >500% | >500% |
| Aged Tensile Strength | >14MPa | >15MPa |
| Aged Elongation | >400% | >450% |
| Residual Powder (ASTM D6124-06) | 230mm | 230-258mm |
| Width | 85-105mm | 85-105mm |
| Palm Thickness | >.050mm | .05-.07mm |
| Unaged Tensile Strength | >14MPa | >16MPa |
| Unaged Elongation | >500% | >500% |
| Aged Tensile Strength | >14MPa | >15MPa |
| Aged Elongation | >400% | >450% |
| Residual Powder (ASTM D6124-06) |
§ 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.