Device
Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the
Manufacturer
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Model: Surgical Gown
DI: 06921825703690
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Distribution End: 2028-04-28
Description
Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 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. It is singleuse, disposable medical devices, provided sterile.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c522205d-cab2-424d-91b5-072e1e348258
Distribution Status:
In Commercial Distribution
DUNS Number:
546983737
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Secondary sales pack
Item #1 - Device ID:
16921825701044
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06921825703690
Item #1 - Pkg Discontinue Date:
2028-04-28
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06921825703690
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35091
Name: Surgical gown, single-use
Definition:
A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
FDA Product Codes
FYA
Gown, Surgical
Premarket Submissions
Submission Number:
K222403
Supplement Number:
000