(78 days)
A 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.
The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.
The provided text describes the acceptance criteria and performance of a Non-sterile, Powder-free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs. This document is a 510(k) Summary.
Here's an analysis of the provided information, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS Used for Acceptance Criteria | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Free Residue | ASTM D 6319-00a-05 | Meets |
| Biocompatibility: Primary Skin Irritation | Rabbits (method not specified in detail) | Passes |
| Biocompatibility: Guinea Pig Sensitization | Guinea Pig (method not specified in detail) | Passes |
| Permeation by Chemotherapy Drugs | ASTM D6978-05 | Passes for all 9 specified chemotherapy drugs |
Comment: The document outlines the specific ASTM standards used for various physical and chemical properties and indicates that the device met these standards or "passed" the tests.
Regarding the study that proves the device meets the acceptance criteria, and further points:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data. It does not describe a clinical study in the typical sense (e.g., involving human subjects, patient data, or a complex AI model evaluation). Instead, it presents laboratory test results against established standards.
Therefore, many of your requested points regarding clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable to this type of device submission and the information provided.
Let's address the relevant points based on the document's content:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of gloves or samples tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The ASTM standards themselves would specify the minimum sample sizes for their respective tests, but this detail is not present in the 510(k) summary.
- Data Provenance: The testing was non-clinical (laboratory and animal studies). The document does not explicitly state the country where the tests were conducted, but the submitter is "Siam Sempermed Corp., Ltd" from Thailand, and the official correspondent is Sempermed USA Inc.
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)
- Not Applicable. This device evaluation relies on objective measurements against engineering and biocompatibility standards, not on expert interpretation of medical images or clinical outcomes. The "ground truth" is defined by the technical specifications and test methods outlined in the ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept is relevant for studies involving human interpretation or subjective assessments, often in clinical imaging. The testing here is based on objective laboratory measurements.
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 device, but not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device. The device itself is the glove, and its performance is measured against physical and chemical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by validated technical standards and test methods (e.g., ASTM D 6319-00a-05 for physical properties, ASTM D6978-05 for chemotherapy drug permeation, and established animal testing protocols for biocompatibility). The acceptance criteria are specified within these standards.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" as it is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
In summary, the provided 510(k) document details how the glove device meets established industry standards for physical properties, biocompatibility, and resistance to chemotherapy drug permeation through laboratory and animal testing. It's a non-clinical submission demonstrating substantial equivalence to a predicate device, and thus, many of the questions related to clinical trials, human expert evaluation, and AI/ML algorithms are not applicable.
§ 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.