(55 days)
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319-00ae3 | Meets ASTM D 6319-00ae3 |
| Physical Properties | Meets ASTM D 6319-00ae3 | Meets ASTM D 6319-00ae3 |
| Freedom from Holes | Meets ASTM D 6319-00ae3 AND Meets ASTM D 5151-99 | Meets ASTM D 6319-00ae3 AND Meets ASTM D 5151-99 |
| Powder-Free | Powder content ≤ 2 mg per glove | Powder content ≤ 2 mg per glove |
| Biocompatibility | ||
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Primary Skin Irritation, Guinea Pig Sensitization). However, it implies that the testing was conducted according to the methodologies outlined in the referenced ASTM standards (ASTM D 6319-00ae3 and ASTM D 5151-99), which would specify sample sizes.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given the context of a 510(k) summary for a medical device seeking market clearance in the US, the testing would typically be conducted by the manufacturer or a contracted lab to generate prospective data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the present submission. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not against "ground truth" established by clinical experts interpreting data.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. The performance is objectively measured against predefined 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves are a physical barrier device, and their performance is assessed through laboratory testing against engineering and biological standards, not through clinical interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical glove, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" in this context is the established performance requirements and methodologies detailed in the referenced ASTM standards:
- ASTM D 6319-00ae3: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D 5151-99: Standard Test Method for Detection of Holes in Medical Gloves
For biocompatibility, the "ground truth" is defined by the "Passes" criteria for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, which are standard biological tests for medical devices.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 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.