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510(k) Data Aggregation
(107 days)
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 minutesWarning / 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 minutesResult: 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 < 2 mg maximum powder per glove. | Average of 0.04 mg/glove (within the powder-free limit). |
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications | Physical dimensions within standard limits. Physical properties meet requirements for tensile strength (e.g., specific MPa before and after aging) and elongation (e.g., specific % before and after aging). Implied minimums are 15 MPa tensile strength before aging and 14 MPa after aging, and 500% elongation before aging and 400% after aging based on predicate. | Physical Dimensions: Within the limits of the standard.Tensile Strength: Average before aging of 30.56 MPa and after aging of 37.53 MPa.Elongation: 593% before aging and 533% after aging. |
| ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization | Not found to cause a sensitizing response or an irritation response in the animal model. | Subject device extracts (polar and non-polar) were not found to cause a sensitizing response or an irritation response in the animal model. |
| ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity | Not found to cause a systemic response in the animal model. | Subject device extracts (polar and non-polar) were not found to cause a systemic response in the animal model. |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state the exact sample sizes for each test (e.g., number of gloves tested for holes, powder). However, it indicates compliance with recognized consensus standards (e.g., ASTM D5151-06, ASTM D6319-10, ASTM D6978-05). These standards prescribe specific sampling plans and test methodologies.
- Data Provenance: The studies were conducted by the manufacturer, Halyard Health, Inc., based in Alpharetta, Georgia, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced standards. The country of origin of the data would therefore be the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This question is not applicable to this type of device and study. The "ground truth" for glove performance is established by the specified methodologies and measurement limits defined within the ASTM and ISO standards themselves, not by human expert consensus or interpretation of images. The tests are laboratory-based, objective measurements (e.g., time to breakthrough, AQL for holes, mg of powder, tensile strength).
4. Adjudication Method for the Test Set:
- None. As explained above, the tests are objective laboratory measurements, not subjective human interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. This document describes the physical and chemical properties of a medical glove.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This question is not applicable. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used:
- Objective laboratory measurements and compliance with established consensus standards. The "ground truth" for this device's performance is derived from the results of standardized physical, chemical, and biological tests, as outlined by ASTM and ISO specifications.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI models, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no training set. The "ground truth" for the performance claims relies on the adherence to and results from validated test methods defined by international standards.
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