Disposable surgical gown - FDA approval
Publish Time: 2022-10-25 Origin: Site
Trade Name: Disposable Surgical Gown
Common Name: Surgical Gown
Model: G4003
Regulatory Information
Classification Name: Gown, Surgical
Classification: Class II
Product code: FYA
Regulation Number: 878.4040
Review Panel: Surgical Apparel
C. Predicate device:
K211809
Surgical Gown
Wuhan Dymex Healthcare Co., Ltd.
D. Indications for use of the device:
1Xiantao Topmed Nonwoven Protective Products Co., Ltd
North of the National Road 318, Tongjiazui Village, Huchang Town, Xiantao City, Hubei Province, China 433000
2 The Disposable Surgical Gowns are intended to be worn by operating room personnel during
surgical procedures to protect the surgical patient and operating room personnel from the transfer of
microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a
surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of
protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single
use, disposable device, provided sterile.
E. Device Description:
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening,
the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made
of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier
level protection for a surgical gown