Search Results

The Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.

The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows: Prevac Steam Sterilization 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time). Medline Item Numbers / gown color / lig. barrier protection / gown size: MDTGBS3CL / Ceil / AAMI Level 3 / Large; MDTGBS3CXL / Ceil / AAMI Level 3 / X-Large; MDTGBS3C2X / Ceil / AAMI Level 3 / XX-Large; MDTGBS3JL / Jade / AAMI Level 3 / Large; MDTGBS3JXL / Jade / AAMI Level 3 / X-Large; MDTGBS3J2X / Jade / AAMI Level 3 / XX-Large.

This document is a 510(k) clearance letter for the Blockade Surgical Gown and does not contain the specific information requested about acceptance criteria and a study proving a device meets those criteria for an AI/ML powered device.

The provided text pertains to a traditional medical device (a surgical gown) and focuses on regulatory clearance based on substantial equivalence to existing predicate devices, rather than a performance study involving acceptance criteria for an AI algorithm.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device