(74 days)
Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
The provided FDA 510(k) clearance letter (K993664) for "Synthetic Vinyl Medical Examination Powdered Gloves" does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are typically associated with diagnostic or AI-powered devices.
Instead, this document is a clearance letter for a Class I medical device (gloves) and pertains to its substantial equivalence to a predicate device already on the market. For such devices, the primary "acceptance criteria" are related to manufacturing quality, safety (e.g., biocompatibility, freedom from harmful substances), and performance standards applicable to gloves (e.g., barrier integrity, tensile strength), rather than detailed clinical performance metrics.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."
Therefore, I cannot provide the requested information as it is not present in the provided document. The 510(k) process for this type of device focuses on demonstrating equivalence to a legally marketed predicate, rather than an extensive clinical study with performance metrics in the way your prompt describes for AI or diagnostic devices.
§ 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.