(117 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Sterile Powder Free Latex Surgical Gloves with Polymer Coating
This document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Latex Surgical Gloves with Polymer Coating." The information provided in this document does not contain details about specific acceptance criteria, study methodologies, or performance data as requested.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Information on experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size or ground truth establishment for the training set.
These details would typically be found in the 510(k) submission itself (the "premarket notification"), which is a more extensive technical document, rather than in the FDA's clearance letter. The letter primarily states the FDA's decision regarding substantial equivalence based on the submitted information.
§ 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).