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510(k) Data Aggregation
(261 days)
The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cladribine (1 mg/ml)
- Cyclophosphamide (20 mg/ml)
- Cytarabine HCl (100 mg/ml)
- Dacarbazine (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 (2 mg/ml)
- Etoposide (20 mg/ml)
- Fludarabine Phosphate (25 mg/ml)
- Fluorouracil (50 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine HCl (38 mg/ml)
- Idarubicin HCl (1 mg/ml)
- Ifosfamide (50 mg/ml)
- Irinotecan HCl (20 mg/ml)
- Leuprolide Acetate (5 mg/ml)
- Mechlorethamine HCl (1 mg/ml)
- Melphalan HCl (5 mg/ml)
- Methotrexate (25 mg/ml)
- Mitomycin C (0.5 mg/ml)
- Mitoxantrone HCl (2 mg/ml)
- Oxaliplatin (5 mg/ml)
- Paclitaxel (6 mg/ml)
- Pemetrexed (25 mg/ml)
- Raltitrexed (0.5 mg/ml)
- Rituximab (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Topotecan HCl (1 mg/ml)
- Trisenox (Arsenic Trioxide) (1 mg/ml)
- Vinblastine Sulfate (1 mg/ml)
- Vincristine (1 mg/ml)
- Vinorelbine Tartrate (10 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
- Thiotepa (10 mg/ml) No breakthrough up to 99.1 minutes.
- Warning- Not for use with Carmustine and ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100 mcg/2 ml)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Chloroquine (50 mg/ml)
- Cyclosporin A (100 mg/ml)
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5" purple‐colored, chlorinated, nitrile, powder‐free, textured fingertip, ambidextrous, sterile patient examination gloves.
The provided text is a 510(k) clearance letter and summary for medical examination gloves, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria or study details such as:
- Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on the physical and chemical properties of the gloves and their resistance to various chemicals, using established ASTM and ISO standards for medical gloves.
However, I can extract the acceptance criteria and reported device performance for these medical gloves based on the provided document.
Analysis of Acceptance Criteria and Device Performance for Medical Gloves
The document details the non-clinical testing performed on the Halyard Purple Nitrile* Powder-Free Exam Gloves to demonstrate their safety and effectiveness. The acceptance criteria and the results of these tests are clearly outlined.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mm | |
| Palm Width Size Small: 70 - 90 mm | |||
| Med: 85–105 mm | |||
| Large: 100 - 120 mm | |||
| Finger thickness ≥0.05 mm | |||
| Palm thickness ≥0.05 mm | |||
| Cuff thickness ≥0.05 mm | Meets requirements | ||
| Physical Properties (Tensile Strength & Elongation) | ASTM D 6319 | AQL 4.0 | |
| Before Aging: | |||
| Tensile Strength: ≥14 MPa | |||
| Ultimate elongation: ≥500% | |||
| After Aging: | |||
| Tensile Strength: ≥14 MPa | |||
| Ultimate elongation: ≥400% | Meets requirements. The physical dimensions and properties (tensile strength before and after aging, and elongation before and after aging) met the requirements of the standard. | ||
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | 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. | ||
| Sterility | ANSI/AAMI/ISO 11137 | 10⁻⁶ | 10⁻⁶ |
| Powder Free | ASTM D 6124, ASTM D 6319 | ≤ 2 mg / glove | Meets requirements. Residual powder on the subject device is an average of 0.4 mg/glove, which is within the powder-free limit of |
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(111 days)
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.
Warning: Not for use with Carmustine, Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile, powder-free, textured, ambidextrous, non-sterile patient examination glove that is packed in a cardboard dispenser box.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Halyard Black Nitrile Powder-Free Exam Gloves.
Based on the provided K242558 510(k) summary, the device is a medical glove, and the studies performed are non-clinical, primarily focused on physical properties, biocompatibility, and resistance to chemical permeation. This is not a study assessing AI performance or human reader effectiveness.
Acceptance Criteria and Reported Device Performance
| Test Method | Standard | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Dimensions | ASTM D6319 | Length: ≥230 mm | PASS |
| Palm Width Size: X-Small: 60 – 80 mm; Small: 70 - 90 mm; Med: 85–105 mm; Large: 100 - 120 mm; X-Large: 110-130 mm; XX-Large: 120-140 mm | PASS | ||
| Finger thickness: ≥0.05 mm | PASS | ||
| Palm thickness: ≥0.05 mm | PASS | ||
| Cuff thickness: ≥0.05 mm | PASS | ||
| Physical Properties | ASTM D6319 | AQL 4.0; Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%; After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | PASS |
| Freedom from Pinholes | ASTM D6319, ASTM D5151 | AQL 2.5%; No leakage | PASS |
| Residual Powder | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove | PASS |
| Permeation by Chemotherapy Drugs | ASTM D6978 | No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCl (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Mitoxantrone HCl (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml). | |
| **Caution (Breakthrough 240 minutes for no breakthrough). |
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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