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510(k) Data Aggregation
(199 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
The provided text is a 510(k) summary for Disposable Powder Free Nitrile Examination Gloves, white and blue colors, tested for use with chemotherapy drugs. It focuses on the safety and effectiveness of the device through non-clinical testing and comparison to a predicate device.
Here's an analysis to extract the requested information, noting that much of it pertains to AI/software device studies and is not applicable to this type of medical glove submission:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance (White Gloves) | Reported Device Performance (Blue Gloves) |
|---|---|---|---|
| Chemotherapy Drug Permeation | ASTM D6978-05 Minimum Breakthrough Detection Time (Min) | ||
| Carmustine (BCNU), 3.3 mg/ml | - (No specific minimum listed, but tested) | 22.8 minutes | 6.2 minutes |
| Thiotepa, 10.0 mg/ml | - (No specific minimum listed, but tested) | 54.6 minutes | 38.8 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Cisplatin, 1.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Fluorouracil, 50.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dimension | ASTM D6319-10(Reapproved 2015) | Complies | Complies |
| Length | ≥ 230mm | Complies (230 mm min) | Complies (230 mm min) |
| Width (Small) | 80 ±10 mm | Complies (80 ±10 mm) | Complies (80 ±10 mm) |
| Width (Medium) | 95 ±10 mm | Complies (95 ±10 mm) | Complies (95 ±10 mm) |
| Width (Large) | 110 ±10 mm | Complies (110 ±10 mm) | Complies (110 ±10 mm) |
| Width (X-Large) | 120 ±10 mm | Complies (120 ±10 mm) | Complies (120 ±10 mm) |
| Thickness (Finger tip) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Thickness (Palm) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Physical Properties | ASTM D6319-10(Reapproved 2015) | ||
| Tensile strength (Before aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Tensile strength (After aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Elongation (Before aging) | ≥ 500% | Complies (≥ 500%) | Complies (≥ 500%) |
| Elongation (After aging) | ≥ 400% | Complies (≥ 400%) | Complies (≥ 400%) |
| Freedom from pinholes | 21 CFR 800.20 and ASTM D6319-10 (Water leak test) | Passed | Passed |
| Powder Residual | ASTM D6319-10 (Test method D5151-06, D6124-06) Acceptance Criteria: < 2 mg/glove | Complies (< 2 mg/glove) | Complies (< 2 mg/glove) |
| Biocompatibility | ISO 10993-10 / ISO 10993-5 (Primary Skin Irritation, Dermal Sensitization, MEM Elution) | Passes (Not a primary skin irritant/sensitizer) | Passes (Not a primary skin irritant/sensitizer) |
Note: The document distinguishes between white and blue gloves for chemotherapy drug permeation times. For other characteristics, it states "White/Blue Color" and indicates compliance with the same standards, implying similar performance unless specified.
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 specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, pinholes, etc.). It refers to compliance with ASTM standards, which would define appropriate sample sizes for those tests.
- Data Provenance: The tests described are "bench testing" performed presumably by the manufacturer (Ever Global (Vietnam) Enterprise Corporation) or a contracted lab. The manufacturer's address is Vietnam. The testing standards are international (ASTM, ISO) and US federal regulations (21 CFR).
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 question is not applicable as this submission is for medical gloves and not a software/AI device that requires expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by the objective measurements outlined in the referenced ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as this is not a study involving subjective human interpretation requiring adjudication. Performance is measured against objective standards.
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
This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a submission for a physical medical device (gloves), not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by objective measurements against recognized international and national standards:
- ASTM D6978-05: For chemotherapy drug permeation breakthrough times.
- ASTM D6319-10: For dimensions, physical properties (tensile strength, elongation), and freedom from pinholes (water leak test).
- 21 CFR 800.20: For freedom from pinholes.
- ASTM D5151-06 (Reapproved 2015) and D6124-06 (Reaffirmation 2011): For powder residual tests.
- ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5: For biocompatibility tests (primary skin irritation, dermal sensitization, MEM Elution).
8. The sample size for the training set
This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" or need for "ground truth" establishment in the AI/ML sense for this device. The standards provide the criteria against which the device's physical and chemical properties are measured.
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