(59 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.
Polymer Coat, Powder Free, Latex Examination Gloves
This is a premarket notification (510(k)) letter from the FDA to Smart Glove Corporation Sdn. Bhd. for their "Polymer Coat, Powder Free, Latex Examination Gloves". The letter grants market clearance based on substantial equivalence to a predicate device.
Unfortunately, the provided text does not contain the acceptance criteria or a study that directly proves the device meets those criteria.
What the document does provide is:
- Device Name: Polymer Coat, Powder Free, Latex Examination Gloves
- Intended Use: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
- Regulatory Class: I
- Product Code: LYY
- 510(k) Number: K991624
To answer your specific questions related to acceptance criteria and a study, this document is insufficient. A 510(k) submission typically includes testing data to demonstrate substantial equivalence, but that data is not part of this public clearance letter. You would need to access the full 510(k) submission (which is generally not publicly available in detail) to find the specific performance data and acceptance criteria.
Therefore, I cannot provide the requested table or detailed study information based on the text provided.
§ 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.