(62 days)
A medical glove is worn on the hand of health care and similar personnel and the patient, A medical glove is worn on one nation between health
BLOSSOM TM Powdered Latex Examination Gloves
I am sorry, but the provided text from the FDA letter and the associated pages (sections 0, 1, and 2) do not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The document is an FDA 510(k) clearance letter for "Blossom Powdered Latex Examination Gloves." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Key information present in the document includes:
- Device Name: Blossom Powdered Latex Examination Gloves
- Applicant: Mexpo International, Incorporated
- 510(k) Number: K984040
- Regulatory Class: I
- Product Code: LYY
- Indications for Use: "A medical glove is worn on the hand of health care and similar personnel and the patient." (This is a generic description for medical gloves and not specific performance criteria).
Therefore, I cannot provide the requested table or details about a study, as that information is not available in the given text.
§ 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.