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510(k) Data Aggregation
(89 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue); Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
This document describes the 510(k) premarket notification for Powder Free Nitrile Examination Gloves (6Mil) and Sterile, Powder Free Nitrile Examination Gloves, both tested for use with chemotherapy drugs (Blue). The key information revolves around the gloves' resistance to permeation by specific chemotherapy drugs.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a single numerical threshold for each drug, but rather presents the average breakthrough detection time for each chemotherapy drug. The implication is that a longer breakthrough time is better, with "> 240 minutes" being the best reported performance for many drugs, suggesting that a 240-minute duration without breakthrough is considered acceptable for practical use. The specific performance for some drugs which are noted as having "extremely low permeation time" for the Sterile glove indicates they do not meet a high standard of protection for those particular drugs.
| Chemo Drug (Concentration) | Acceptance Criteria (Implied) | Powder Free Nitrile (6mil) Performance (Average Breakthrough Time in Minutes) | Sterile, Powder Free Nitrile Performance (Average Breakthrough Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) (3.3 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 111.9 | 0.51 (Noted as "extremely low") |
| Thiotepa (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 162.3 | 36.5 (Noted as "extremely low") |
| Fluorouracil (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitomycin C (0.5 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Methotrexate (25.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cisplatin (1.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitoxantrone (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Ifosfamide (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Vincristine Sulfate (1.0mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
The acceptance criteria for glove performance against chemotherapy drugs generally follow standards like ASTM D6978, which specifies a minimum breakthrough time. While not explicitly stated as "acceptance criteria," the consistent reporting of "> 240 minutes" for many drugs suggests that 240 minutes is the target threshold for extended protection. The note concerning Carmustine and Thiotepa for the Sterile gloves indicates that their performance of < 30 minutes / 60 minutes is considered unacceptably low for prolonged exposure.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on:
- The specific sample size (number of gloves or repetitions) used for testing each chemotherapy drug.
- The data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device (nitrile examination gloves) and study. The "ground truth" for chemical permeation is established through laboratory testing using standardized methods (likely an ASTM standard, e.g., ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), not through expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication is typically relevant for studies involving human interpretation or subjective assessments. Chemical permeation testing is an objective laboratory measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this device. This type of study assesses the performance of human readers, often with and without AI assistance, in interpreting medical images or data. The current device is a physical product (gloves), and its performance is measured through objective chemical tests.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. "Standalone performance" refers to the performance of an AI algorithm without human involvement. The current device is a physical product, not an AI or software algorithm. The study described is a laboratory test of its physical properties.
7. Type of Ground Truth Used
The ground truth used is based on objective laboratory measurements of chemical permeation, likely following a recognized standard such as ASTM D6978. The "ground truth" is the measured average breakthrough detection time of the chemotherapy drug through the glove material.
8. Sample Size for the Training Set
This information is not applicable. The study described is not a machine learning or AI-based study that would require a training set. It is a laboratory performance test of a physical product.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device and study.
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