(114 days)
The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a surgical glove. The provided text does not contain any information about acceptance criteria, study details, or device performance data.
The document primarily focuses on:
- Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
- FDA Clearance: Confirmation of substantial equivalence to a predicate device.
- Regulatory Information: General controls provisions, potential additional controls, contact information for regulatory guidance.
- Indications for Use: Stating the purpose of the surgical gloves (protection of a surgical wound from contamination).
Therefore, I cannot provide the requested table and study details based on the given input. To answer your request, I would need a document that includes performance data for the device, such as a summary of safety and effectiveness (SSE) report or a clinical study report that details the testing performed to demonstrate the device meets certain criteria.
§ 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).