(255 days)
Sterile Surgical Powder Free Latex Glove is a disposable device intended for medical purposed that is worn on by operating room personnel to protect a surgical wound from contamination.
Sterile Surgical Powder Free Latex Glove
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Sterile Surgical Powder Free Latex Glove," indicating that the device has been found substantially equivalent to a predicate device.
The information primarily consists of:
- FDA 510(k) Clearance Details: Device name, applicant, regulation number, product code, and clearance date.
- Regulatory Information: References to general controls, other regulations (like registration, labeling, medical device reporting), and contact information for FDA assistance.
- Indications for Use: A description of how the surgical glove is intended to be used.
There is no mention of specific acceptance criteria, performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).