(397 days)
The ROMED surgeon sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The ROMED surgeon's gloves are made of natural rubber, sterile and powdered with USP absorbable dusting powder. E.P. content is less than 100 µg/gm. Surgeon's gloves are in conformity with ASTM D3577-00a standard.
I am sorry, but the provided text does not contain the detailed study information required to answer your request about acceptance criteria and device performance for the "latex surgeon's sterile, powdered gloves."
The document primarily consists of a 510(k) summary and an FDA clearance letter. While it mentions the device conforms to ASTM D3577-00a standard and lists some general "testing" categories (Shelf life, primary skin irritation test, guinea pig maximization test, toxicity), it does not provide:
- Specific acceptance criteria values.
- The reported device performance against those criteria.
- Details of any study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set information).
The "SUMMARY OF SUBSTANTIAL EQUIVALENCE" and "CONCLUSION" sections state that the device is substantially equivalent to predicate devices and meets minimum requirements, but they don't elaborate on the specific studies or data that demonstrate this.
Therefore, I cannot generate the requested table and study information based on the given input.
§ 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).