Search Results
Found 1 results
510(k) Data Aggregation
(56 days)
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
Surgical gown is 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.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
The proposed devices 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 proposed devices are single use, disposable medical devices and are provided in sterile.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
Acceptance Criteria and Device Performance Study for Surgical Gowns (K211422)
This document describes the acceptance criteria and the studies performed to demonstrate that the Jiangsu Medplus Non-woven Manufacturer Co., Ltd. Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, and Level 3 Reinforced Surgical Gown meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing Methodology | Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|---|
| Flammability (16 CFR Part 1610) | Meets Class 1 requirements | Pass |
| Hydrostatic pressure (AATCC 127: 2017) | Level 2 Standard Surgical Gown: >20 cm | |
| Level 3 Standard Surgical Gown: >50 cm | ||
| Level 3 Reinforced Surgical Gown: >50 cm | Level 2 Standard Surgical Gown: 37.6 cm | |
| Level 3 Standard Surgical Gown: 52.6 cm | ||
| Level 3 Reinforced Surgical Gown: 83.1 cm | ||
| Water impact (AATCC 42: 2017) | ≤1.0 g | Level 2 Standard Surgical Gown: 0.4 g |
| Level 3 Standard Surgical Gown: 0.5 g | ||
| Level 3 Reinforced Surgical Gown: 0.2 g | ||
| Breaking strength (ASTM D5034: 2009(2017)) | >20N | Level 2 Standard Surgical Gown: 73N |
| Level 3 Standard Surgical Gown: 70.3N | ||
| Level 3 Reinforced Surgical Gown: 45.6N | ||
| Tearing strength (ASTM D5587: 2015(2019)) | >20N | Level 2 Standard Surgical Gown: 24.1N |
| Level 3 Standard Surgical Gown: 48.4N | ||
| Level 3 Reinforced Surgical Gown: 24.6N | ||
| Linting (ISO 9073-10: 2003) | Log10 (particle count) 30 ft³/min/ft² | Level 2 Standard Surgical Gown: 32.9 ft³/min/ft² |
| Level 3 Standard Surgical Gown: 33.8 ft³/min/ft² | ||
| Level 3 Reinforced Surgical Gown: 31.7 ft³/min/ft² | ||
| EO/ECH Residue (ISO 11135:2014 Annex B) | EO: |
Ask a specific question about this device
Page 1 of 1