(53 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.
Sterile Powder Free Latex Examination Gloves With Protien Claim : (50 micrograms/g Of Gloves.or less)
The provided document does not contain information about the acceptance criteria or a study that proves a device meets such criteria.
The document is a letter from the Food and Drug Administration (FDA) to Smart Glove Corporation Sdn. Bhd. regarding the substantial equivalence determination for their "Sterile Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)".
It is a regulatory approval letter, not a technical report detailing performance criteria or study results.
§ 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.