(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 |
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.