KP Protective Face Mask

Basic Information

• Brand Name: KP Protective Face Mask
• Primary DI: 08809755250171
• Version / Model: Large-White
• Company Name: KP trading Co., Ltd.
• Labeler DUNS: 695645209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: f1d02201-17f3-4e66-b9f3-d3417b6dd64a

Device Description

KP Protective Face Mask is a single-use, disposable surgical face mask intended to be worn by healthcare professionals to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. The mask covers the nose and mouth and is secured with ear loops. It is intended for use in medical and surgical settings. The mask is non-sterile and for single use only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66199	Surgical/medical face mask, non-antimicrobial, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08809755250164	GS1	Box	50	In Commercial Distribution
Primary	08809755250171	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243342	000