(80 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powder Free Latex Surgical Gloves with Protein Labeling Claim ( 50 micrograms or less )
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the device. The document is an FDA 510(k) clearance letter for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to a predicate device.
The document includes:
- Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)
- Regulation Number/Name: 878.4460 / Patient Examination Gloves
- Regulatory Class: I
- Product Code: KGO
- Indications For Use: A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table and information about the study.
§ 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).