(38 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
SMARTTEX Powder Free Latex Examination Gloves, with protein labeling claim ('50 micrograms or Less) NATURAL, BLUE & GREEN Colored
The provided text is a 510(k) premarket notification letter from the FDA regarding "SMARTTEX Powder Free Latex Examination Gloves, with Protein Content Labeling Claim (50 Micrograms or Less (Natural, Blue and Green Colored))".
This document is a regulatory approval letter for a medical device (examination gloves) and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically found in reports for AI/software-based medical devices.
Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and can therefore be marketed. The "Indications for Use" section simply describes the intended purpose of the gloves: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
Therefore, I cannot provide the requested information as it is not present in the given text. The questions posed are relevant to the evaluation of AI/software devices, which this product is not.
§ 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.