Search Results
Found 1 results
510(k) Data Aggregation
(268 days)
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:
| Title of Test | Purpose of Test | Acceptance Criteria | Results (Level 2 gown) | Results (Level 3 gown) |
|---|---|---|---|---|
| AATCC127: 2018 | Water resistance/Hydrostatic Pressure | ≥ 20 cm (Level 2) | ||
| ≥ 50 cm (Level 3) | Passed | Passed | ||
| AATCC42: 2017 | Water Resistance Impact Penetration | ≤ 1.0 g | Passed | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean ≥ 30 N; | ||
| CD Mean ≥ 30 N | Passed | Passed | ||
| ASTM D5733-99 | Tearing Strength | MD Mean ≥ 10 N; | ||
| CD Mean ≥ 10 N | Passed | Passed | ||
| ISO 9073-10: 2003 | Linting | Average ≤ 10000 (Log L |
Ask a specific question about this device
Page 1 of 1