(106 days)
A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
The provided text is related to an FDA 510(k) premarket notification for a medical device: "Colored Powder Free and Polymer Coated Latex Examination Glove (Blue, Black and Pink) with a Protein Claim of Less than 50 ug/gm Glove".
This document is an FDA clearance letter, not a study report or a summary of acceptance criteria and performance data for a device. It confirms that the device is substantially equivalent to a legally marketed predicate device. Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not present in the provided text.
The document states the "Indications For Use" for the glove:
"A colored, powder free and polymer-coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove."
The primary performance claim highlighted is "with a Protein Claim of Less than 50 ug/gm Glove." However, the document does not detail the specific test methods, acceptance criteria, or the study results that demonstrate this claim. Such information would typically be found in the 510(k) submission itself, not the FDA's clearance letter.
§ 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.