(39 days)
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
LATEX EXAMINATION GLOVES, POWDERFREE
This document is an FDA 510(k) clearance letter for "Latex Examination Gloves Powderfree" from Innovative Gloves Company, Ltd. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
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..."
This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its efficacy or performance against specific, new acceptance criteria. The clearance is based on the assumption that if it's substantially equivalent to a device already on the market, it meets the inherent safety and performance standards for that product type.
Therefore, I cannot provide the requested information from this document because it is not present. The document only confirms the FDA's decision regarding market clearance of the 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.