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510(k) Data Aggregation
(88 days)
Genabio Diagnostics Inc
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(183 days)
Genabio Diagnostics Inc.
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powderfree, ambidextrous with beaded cuff, purple colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.
Here's a breakdown of the acceptance criteria and study information for the GenaCheck™ Nitrile Powder Free Examination Glove, based on the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Property | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance (ASTM D6319-19) | |||
| Length | Physical Dimensions Test | XS/S: ≥220 mm; M/L/XL: ≥230 mm | XS/S: ≥220 mm (Pass); M/L/XL: ≥230 mm (Pass) |
| Width | Physical Dimensions Test | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | XS: 73-78 mm (Pass); S: 84-88 mm (Pass); M: 93-98 mm (Pass); L: 103-108 mm (Pass); XL: 113-118 mm (Pass) |
| Thickness | Physical Dimensions Test | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Finger: 0.069-0.109 mm (Pass); Palm: 0.052-0.079 mm (Pass) |
| Watertightness (ASTM D5151-19) | |||
| Freedom from Holes | Watertightness Test | Met the requirements of ASTM D5151 AQL 2.5 | 0/125 (Pass) |
| Powder Content (ASTM D6124-06) | |||
| Powder Content | Powder Content | Meet the requirements of ASTM D6124 240 Minutes | |
| Cyclophosphamide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Dacarbazine (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Doxorubicin HCI (2.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Etoposide (20.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fluorouracil (50.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Methotrexate (25.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Mitomycin C (0.5 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Paclitaxel (6.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Thiotepa (10.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table, but the indication highlights "low permeation time" | 37.9 Minutes |
| Vincristine Sulfate (1.0 mg/ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
| Fentanyl Citrate Inj. (100mcg/2ml) | Breakthrough Detection Time | No explicit acceptance criterion defined in the table | > 240 Minutes |
Study Details:
For medical gloves, the "study" demonstrating that the device meets acceptance criteria typically refers to a series of non-clinical, laboratory bench tests conducted according to recognized consensus standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it references the standards used, which often specify sample sizes.
- For Watertightness Test (ASTM D5151-19), the result "0/125/Pass" indicates that 125 samples were tested, with 0 failures.
- For other tests like physical dimensions, powder content, and physical properties, the sample sizes are described by the respective ASTM standards but not explicitly listed in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical testing" (bench tests) rather than human subject studies, so there's no "retrospective or prospective" status in the same sense as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of device and study. The "ground truth" for non-clinical performance and material properties standards is established by the specifications defined within the referenced ASTM and ISO standards themselves (e.g., a tensile strength of ≥14 MPa, or a specific AQL for holes). There are no human experts classifying outcomes in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" are used for human-reviewed data sets (e.g., medical image interpretation consensus). For bench testing against pre-defined engineering and material specifications, the results are quantitative measurements compared directly to the acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of diagnostic tools (e.g., AI algorithms for interpreting medical images) with and without human readers' involvement. The device here is a medical glove, for which MRMC studies are not applicable.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study in the context of an "algorithm only" performance was not done. This concept is specific to software medical devices or AI algorithms. The GenaCheck™ glove is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on established industry and regulatory standards.
- For physical properties, it's defined quantities like minimum tensile strength (e.g., ≥14 MPa).
- For resistance to permeation by chemotherapy drugs, it's the measured "breakthrough detection time" according to the specified method (ASTM D6978-05).
- For biocompatibility, it's the absence of adverse biological reactions (non-irritating, non-sensitizing, no acute systemic toxicity, and comparison to predicate regarding cytotoxicity) as defined by ISO 10993 series.
8. The Sample Size for the Training Set
There is no training set for this device. Training sets are applicable to machine learning algorithms. The GenaCheck™ glove is a physical product, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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