(457 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
I am sorry, but the provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This product is a medical device, but it is not an AI/ML-powered device for which the requested information about acceptance criteria, study details, expert involvement, and training/test set specifics would typically apply.
The document focuses on demonstrating substantial equivalence to a predicate device based on standard performance tests for gloves (e.g., ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility (ISO 10993-10). It does not involve any AI/ML components or the kind of study design that would address the detailed questions you've asked.
Therefore, I cannot provide the requested information from the given input.
§ 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.