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510(k) Data Aggregation
(45 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml ≥ 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes
Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Not recommended for use with these drugs.
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.
The provided document is a 510(k) Premarket Notification for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. It details the acceptance criteria and performance data for this medical device, which is a non-powdered patient examination glove.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥ 220, M/L/XL: ≥ 230Width (mm): S: 80 ± 10, M: 95 ± 10, L: 110 ± 10, XL: 120 ± 10Thickness (mm): Finger: ≥ 0.05, Palm: ≥ 0.05 | Length (mm): S: ≥ 220 / Pass, M/L/XL: ≥ 230 / PassWidth (mm): S: 82 – 85 / Pass, M: 95 – 97 / Pass, L: 103 – 107 / Pass, XL: 110 – 116 / PassThickness (mm): Finger: 0.13 – 0.17 / Pass, Palm: 0.09 – 0.11 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | S: 1/125 / Pass, M: 2/125 / Pass, L: 2/125 / Pass, XL: 4/125 / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.4 mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 500%Meet the requirements of ASTM D412 AQL 4.0 | Tensile Strength: 14 – 19 MPa / PassUltimate Elongation: 515 – 540% / Pass1/13 / Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 400% | Tensile Strength: 15 – 20 / PassUltimate Elongation: 468 – 525 / Pass |
| ISO 10993-5 | Cytotoxicity | Non-In Vitro Cytotoxicity | Under conditions of the study, device extract is cytotoxic. (This result seems to contradict "Non-In Vitro Cytotoxicity" as an acceptance criterion unless the intended criterion was 'not cytotoxic' and the result indicates it did not meet this specific aspect, or it's phrased poorly and means no in-vitro cytotoxicity observed that would deem it unsafe). Correction: The phrasing in the document is "Under conditions of the study, device extract is cytotoxic." which implies failure if the acceptance criteria truly was "Non-In Vitro Cytotoxicity". However, given the overall conclusion of substantial equivalence, this specific wording might be an error or interpreted differently. |
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | Breakthrough times for various chemotherapy drugs. (Specific numerical criteria for individual drugs are not explicitly stated as "acceptance criteria" but are implied by the predicate comparison and the statement that some drugs are "Not recommended for use.") | Breakthrough times reported for various chemotherapy drugs, including specific times for Carmustine (35.8 Minutes) and Thio-Tepa (87.0 Minutes). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the overall sample sizes for all tests beyond what is indicated in specific test results (e.g., in ASTM D5151, the number of gloves tested per size is implied by the X/125 format, and in ASTM D412 AQL, 1/13 is mentioned). The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned. The tests are non-clinical, meaning they are laboratory-based, not patient-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized ASTM and ISO standards for physical, chemical, and biocompatibility properties. There are no human experts involved in establishing a "ground truth" in the way one would for diagnostic imaging. The measurements are objective, per standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed against predefined statistical and physical thresholds in standardized tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on scientific and engineering standards for material properties, dimensions, physical performance, and biocompatibility, as defined by ASTM International and ISO. Examples include:
- Physical Dimensions: Measured and compared against ranges specified in ASTM D6319.
- Watertightness: Assessed by the AQL (Acceptable Quality Level) specified in ASTM D5151.
- Biocompatibility: Determined by adherence to ISO 10993 standards for cytotoxicity, systemic toxicity, irritation, and sensitization.
- Chemotherapy Drug Permeation: Measured breakthrough times as per ASTM D6978-05.
8. The sample size for the training set
Not applicable. This device is a medical glove, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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