Device
Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is inten...
Manufacturer
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Model: Tie-on type
DI: 06921825703607
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
Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided as sterile.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
dc59b509-a44b-4724-8e40-8f682111b153
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:
16921825700979
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1000
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06921825703607
Item #1 - Pkg Discontinue Date:
2028-04-28
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06921825703607
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 66199
Name: Surgical/medical face mask, non-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 does not include an antimicrobial/antiviral agent(s) 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:
K222545
Supplement Number:
000