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510(k) Data Aggregation
(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.
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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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