Device
Disposable Medical Face Masks (Ear Loop)
Manufacturer
Premium Plus (Dongguan) Limited
Premium Plus (Dongguan) Limited
Model: 2288L
Catalog: 2288
DI: D1252288L2
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Disposable Medical Face Masks (Ear Loop)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2a983a85-d1f0-4546-bcf0-c83303730876
Distribution Status:
In Commercial Distribution
DUNS Number:
541637603
Device Count:
50
DM Exempt:
Yes
Premarket Exempt:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
D1252288L8
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
D1252288L2
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D1252288L2
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
Item #3 - Device ID:
D1252288L0
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
HIBCC
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
LYU
Accessory, Surgical Apparel