(98 days)
A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Master Guard Disposable Nitrile Powdered Blue Examination Gloves
This FDA 510(k) clearance letter for "Master Guard Disposable Nitrile Powdered Blue Examination Gloves" does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way requested.
The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device, which means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976.
Specifically, the document does not provide any information for the following requested items:
- A table of acceptance criteria and the reported device performance: This type of data is typically found in a summary of safety and effectiveness or a test report, not in the clearance letter itself.
- Sample size used for the test set and the data provenance: There is no mention of specific test sets or their size/origin.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no such test is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable (this is a physical glove, not an AI algorithm).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (this is a physical glove, not an AI algorithm).
- How the ground truth for the training set was established: Not applicable.
The document does state the Indications for Use:
"A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
To find information on acceptance criteria and performance data for this type of device, one would typically need to refer to:
- Voluntary consensus standards: Such as ASTM standards for medical examination gloves (e.g., ASTM D6319 for nitrile examination gloves), which define performance requirements for properties like tensile strength, elongation, puncture resistance, and barrier integrity (e.g., AQL for pinholes).
- The 510(k) submission itself: The actual submission would contain the test reports and data that demonstrate the device meets these standards and any other specific performance claims, enabling the FDA to determine substantial equivalence.
Without access to the actual 510(k) submission, the requested information cannot be extracted from the provided text.
§ 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.