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Y ADU Surgical Gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

Y ADU Surgical Gowns provide Level 2 and Level 3 protections per ANSI/AAMI PB70 standard.

Y ADU Surgical Gowns (Level 2) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-2 protection.

The Level 2 Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbonded and meltblown polypropyle.

The body and sleeve is made from 35g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 35g Blue SMMS.

Y ADU Surgical Gowns (Reinforced, Level 3) are made from SMMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The chest area is reinforced with layer of PE+SPP material. They provide AAMI Level-3 protection.

The Level 3 Reinforced Gowns have six different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL), and Super Extra large (XXXL).

SMMS is a multi-ply material consisting of layers of spunbond and meltblown polypropyle.

The body and sleeve is made from 45g Blue SMMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. The belt is made from 45g Blue SMMS. The reinforced area is made from PE +SPP material.

All gowns are sterilized with ethylene oxide.

This document describes the YADU Surgical Gowns (K220092) and their conformance to safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.

The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter. Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex. Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire. The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.

This document is a 510(k) Pre-Market Notification for YADU Surgical Masks, demonstrating its substantial equivalence to a legally marketed predicate device. The information provided focuses on the technical performance of the surgical masks rather than an AI/ML powered device. Therefore, a direct mapping to the requested information about an AI/ML device is not fully applicable. However, I will extract relevant information from the provided text that corresponds to the structure of your request, interpreting "device" as the surgical mask in this context.

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1. A table of acceptance criteria and the reported device performance

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