(29 days)
A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES
The provided text is a 510(k) premarket notification letter from the FDA to Kana Latex Industries Pvt. Ltd. regarding "Pre-Powdered Sterile Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.
The letter is a regulatory approval document, affirming that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general controls under the Food, Drug, and Cosmetic Act.
Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study information, or expert ground truth based on the provided 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.