Device
Surgical face mask, ASTM Level 3, Blue, 17.5x9.5cm-3ply
Manufacturer
Kingstar Medical (Xianning) Co., Ltd.
Kingstar Medical (Xianning) Co., Ltd.
Model: ASTM Level 3
DI: 56936662656110
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-01
Current Version: 2026-05-19
Description
Surgical face mask, ASTM Level 3, Blue, 17.5x9.5cm-3ply
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
65350714-e706-4ae4-9a1b-1a2970513946
Distribution Status:
In Commercial Distribution
DUNS Number:
554427461
Device Count:
50
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
Item #1 - Device ID:
06936662656115
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
56936662656110
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
case
Item #3 - Device ID:
76936662656114
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
40
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
56936662656110
Item #3 - 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:
K232359
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep dry
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep away from sunlight