Device
FDA 510(k) K211984, ASTM F2100-19 LEVEL 3 - Ear-loop Blue surgical masks
Manufacturer
Mid-america Safety Corp.
Mid-america Safety Corp.
Model: 860006984205
DI: 00860006984205
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
FDA 510(k) K211984, ASTM F2100-19 LEVEL 3 - Ear-loop Blue surgical masks
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
409e7aa1-7dbb-4a10-ae00-886cd7ddbdb5
Distribution Status:
In Commercial Distribution
DUNS Number:
117868384
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:
Yes
Identifiers
Device ID:
00860006984205
Type:
Primary
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:
K211984
Supplement Number:
000