Device
Level 3 Surgical Gown (Standard & Reinforced) are sterile, single-use surgical apparel intended tobe worn by healthcare professionals during surgical procedures to provide barrier...
Manufacturer
YADU Medical (Henan) Co., Ltd.
YADU Medical (Henan) Co., Ltd.
Model: Standard--XL
DI: 06979247712035
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-17
Current Version: 2026-05-25
Description
Level 3 Surgical Gown (Standard & Reinforced) are sterile, single-use surgical apparel intended tobe worn by healthcare professionals during surgical procedures to provide barrier protection againstthe transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both
patients and healthcare personnel.
The products meet the respective liquid barrier performance requirements for Level 3 as specified inANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel anddrapes intended for use in health care facilities".
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5fe18884-8524-429c-90ba-550da9711a41
Distribution Status:
In Commercial Distribution
DUNS Number:
542078504
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06979247712035
Type:
Primary
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:
K250564
Supplement Number:
000