Device
YADU Surgical Masks (Model E (ear loops, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile) are intendedto be worn to protect both the patient and healthcare person...
Manufacturer
HENAN YADU INDUSTRY CO., LTD.
HENAN YADU INDUSTRY CO., LTD.
Model: Ear loops (Model E)
DI: 06946015152119
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
YADU Surgical Masks (Model E (ear loops, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile) are intendedto be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, andparticulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood andbody fluids. This is a single use, disposable device, provided sterile and non sterile.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6e50352e-e338-4571-bc4a-b0b4d5472560
Distribution Status:
In Commercial Distribution
DUNS Number:
421327507
Device Count:
50
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
06946015152119
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16946015152116
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
16946015152116
Item #3 - Device ID Type:
Direct Marking
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 66197
Name: Surgical/medical face mask, antimicrobial, single-use
Definition:
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
FDA Product Codes
FXX
Mask, Surgical
Premarket Submissions
Submission Number:
K212330
Supplement Number:
000