(134 days)
A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient.
LATEX EXAMINATION GLOVE, POWDER-FREE
This document is a 510(k) clearance letter from the FDA for "Latex Exam Gloves 50 mcgm or Less of Total Water Extractable Protein Per Gram" by Shun Thai Rubber Gloves Company, Limited, dated November 24, 1998. It primarily deals with the regulatory approval for a medical device and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report or performance evaluation.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms that the device is "substantially equivalent" to predicate devices based on its indications for use, but it doesn't provide the specifics of the performance criteria or the study data used to demonstrate that equivalence.
§ 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.