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510(k) Data Aggregation
(107 days)
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
The Halyard Lavender Nitrile Powder-Free Exam 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 the following chemotherapy drugs:
- Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
- Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
- 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
- Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
- Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
- Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
- Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
- Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
- Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
- ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
Warning: Not for Use With : Carmustine, ThioTEPA
Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
The provided text describes the regulatory clearance (510(k)) for a medical device: "Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating AI-powered diagnostic performance. Therefore, many of the requested elements for AI/diagnostic device acceptance criteria and study design (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to this type of device and regulatory submission.
However, I can extract the acceptance criteria and performance data relevant to this product, which primarily involve physical and chemical resistance standards for medical gloves.
Here's the information gleaned from the provided text, adapted to the context of this device:
Device: Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Type of Regulatory Submission: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)
Study Focus: Performance of the glove against established consensus standards for medical gloves and resistance to chemotherapy drug permeation. This is not a study evaluating AI diagnostic performance or human reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
| Standard/Test | Acceptance Criteria | Reported Device Performance (Halyard Lavender Nitrile Powder-Free Exam Glove) |
|---|---|---|
| ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Breakthrough times for listed chemotherapy drugs (the specific criteria for each drug are implied by the "No breakthrough up to X minutes" statement for the predicate and subject device, along with the warning for Carmustine and ThioTEPA). The underlying acceptance criterion would be defined by the manufacturer's target for 'no breakthrough' for the specific duration of use they claim. | No signs of breakthrough after 4 hours for 10 drugs: |
| • Cyclophosphamide (20.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Doxorubicin HCl (2.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Etoposide (20.0 mg/ml): No breakthrough up to 240 minutes | ||
| • 5-Fluorouracil (50.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Paclitaxel (Taxol) (6.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Cisplatin (1.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Dacarbazine (10.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Ifosfamide (50.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Mitoxantrone (2.0 mg/ml): No breakthrough up to 240 minutes | ||
| • Vincristine sulfate (1.0 mg/ml): No breakthrough up to 240 minutes |
Warning / Limited Breakthrough:
• Carmustine (3.3 mg/ml): No breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg/ml): No breakthrough up to 30.9 minutes
Result: Meets acceptance criteria. (Note: The product warning explicitly states "Not for Use With: Carmustine, ThioTEPA" due to these short breakthrough times.) |
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves | Meets 2.5% AQL (Acceptable Quality Level) requirement for leakage. | Actual AQL of 1.0% (lower is better, indicating fewer holes). |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Powder-free limit of
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