ZhengKang

Basic Information

• Brand Name: ZhengKang
• Primary DI: 06973824915680
• Version / Model: ZKM-U01
• Company Name: Guangzhou Zhengkang Medical Equipment Co., Ltd.
• Labeler DUNS: 554549693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-12-06
• Public Version: 2
• Public Version Date: 2022-11-16
• Public Version Status: Update
• Public Device Record Key: 3a15494e-7d0d-46b0-8cf3-4a1c9e61a869

Device Description

Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile.

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: No
• 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: No
• 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
64821	Public face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973824915680	GS1
Unit of Use	06973824915697	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212460	000