(74 days)
A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, contagious issue by the world. In the dentistry field.
Patient Examination Glove Oleicon Powder free polymer coated berce Cot Bubblegum ssented NR latef
The provided text is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)". This document is a regulatory approval for a medical device and does not contain any information about a study proving the device meets acceptance criteria.
The FDA letter grants substantial equivalence based on the device's similarity to a legally marketed predicate device, not on specific performance studies detailed in this document. Therefore, I cannot provide the requested information.
The document indicates:
- Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)
- Regulation Number/Name: 880.6250 / Patient Examination Glove
- Regulatory Class: I
- Product Code: LYY
- Indications for Use: A disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination and in the dentistry field.
To answer your specific questions, one would need access to the full 510(k) submission documentation, which would include the raw data and study reports if they were required and submitted. The letter itself only confirms the FDA's decision based on that submission.
§ 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.