(96 days)
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
The document provided is a 510(k) premarket notification for "POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria, statistical analysis, and expert ground truth consensus typical for AI-powered diagnostic devices.
Therefore, the requested information about acceptance criteria, efficacy study design, sample sizes for test and training sets, expert qualifications, and adjudication methods (sections 1-9 of your prompt) does not directly apply in the context of this 510(k) submission for medical gloves.
The "study" in this context refers to bench testing against established industry standards for medical gloves, and the "acceptance criteria" are the performance specifications outlined in those standards.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are derived from various ASTM and ISO standards for medical gloves. The reported device performance indicates compliance with these standards.
| Acceptance Criterion (from relevant standard) | Reported Device Performance |
|---|---|
| Chemotherapy Drug Permeation (ASTM D6978-05) | |
| Fluorouracil: Breakthrough Detection Time | > 240 minutes |
| Etoposide (Toposar): Breakthrough Detection Time | > 240 minutes |
| Cyclophosphamid (Cytoxan): Breakthrough Detection Time | > 240 minutes |
| Carmustine (BCNU): Breakthrough Detection Time | 45.0 minutes |
| Thiotepa: Breakthrough Detection Time | 30.0 minutes |
| Paclitaxel (Taxol): Breakthrough Detection Time | > 240 minutes |
| Doxorubicin Hydrochloride: Breakthrough Detection Time | > 240 minutes |
| Dacarbazine (DTIC): Breakthrough Detection Time | > 240 minutes |
| Cisplatin: Breakthrough Detection Time | > 240 minutes |
| Carboplatin: Breakthrough Detection Time | > 240 minutes |
| Docetaxel: Breakthrough Detection Time | > 240 minutes |
| Ifosfamide: Breakthrough Detection Time | > 240 minutes |
| Irinotecan: Breakthrough Detection Time | > 240 minutes |
| Mechlorethamine HCL: Breakthrough Detection Time | > 240 minutes |
| Methotrexate: Breakthrough Detection Time | > 240 minutes |
| Mitomycin C: Breakthrough Detection Time | > 240 minutes |
| Mitoxantrone: Breakthrough Detection Time | > 240 minutes |
| Vincristine Sulfate: Breakthrough Detection Time | > 240 minutes |
| Physical Properties - Before Aging (ASTM D6319-10) | |
| Tensile Strength | 15 Mpa, min |
| Ultimate Elongation | 500% min |
| Physical Properties - After Aging (ASTM D6319-10) | |
| Tensile Strength | 14 MPa, min |
| Ultimate Elongation | 400% min |
| Freedom from Holes (ASTM D5151-06) | Free from holes, AQL 1.5 |
| Powder Content (ASTM D6124-06) | Max. 0.32 mg per glove |
| Biocompatibility - Irritation (ISO 10993-10) | Not an irritant |
| Biocompatibility - Sensitization (ISO 10993-10) | Not a sensitizer |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test within the standards (e.g., how many gloves were tested for permeation, holes, etc.). However, it refers to standards like ISO 2859-1:1999 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection"), which would dictate the sample sizes used for quality control aspects like freedom from holes.
The data provenance is from bench testing conducted by the manufacturer, Hebei Hongsen Plastics Technology Co., Ltd. The country of origin for the manufacturing and testing data would be China, as indicated by the manufacturer's address. This is retrospective testing performed to demonstrate compliance for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert consensus on clinical data interpretation. The tests are objective measurements (e.g., breakthrough time, tensile strength, presence of holes).
4. Adjudication method for the test set
Not applicable. The tests are objective measurements according to standardized protocols, eliminating the need for adjudication among human readers.
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 is a medical glove, not an AI-powered diagnostic device. No human-in-the-loop performance or AI assistance considerations are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective measurements and adherence to performance specifications defined in international and national standards, such as:
- Physical properties (tensile strength, elongation)
- Dimensional properties (length, width, thickness)
- Freedom from holes
- Chemical permeation (chemotherapy drugs)
- Biological safety (irritation, sensitization)
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. The manufacturing process is designed to produce gloves meeting specifications, and the testing confirms this.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.