(99 days)
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Powdered
This document is a 510(k) premarket notification for Vinyl Examination Gloves, Powdered. It is a clearance letter from the FDA. This type of document, particularly for a Class I device like examination gloves, does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the same way a software device submission would.
Medical gloves are considered a low-risk device and their substantial equivalence is primarily based on performance standards and material specifications, rather than complex clinical studies or AI algorithm performance.
Therefore, I cannot provide the requested information because it is not present in the provided document and is generally not applicable to the FDA clearance process for a device of this type.
Here’s why the requested information isn't available for this document:
- Acceptance Criteria & Device Performance: For gloves, the acceptance criteria are typically related to physical properties (tensile strength, elongation, freedom from holes) and chemical safety (biocompatibility). The document mentions the device but does not provide a table of these performance metrics.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are concepts primarily relevant to diagnostic algorithms, AI, or higher-risk devices requiring clinical trials, not basic medical devices like examination gloves. The document confirms substantial equivalence to a predicate device, which means direct comparative testing might have been done for certain physical properties, but not in the format of a "study" with AI or human readers.
- Ground Truth: For gloves, the "ground truth" would be objective measurements of their physical properties and sterility/biocompatibility, not an expert consensus on a diagnosis.
- Training Set: There is no "training set" for a physical device like a glove. This concept applies to machine learning algorithms.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a low-risk medical device (vinyl examination gloves). The detailed study information requested is not part of this type of submission for this particular 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.