ZhengKang

GUDID 06973824910647

Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Guangzhou Zhengkang Medical Equipment Co., Ltd.

Public face mask, single-use

• Primary Device ID: 06973824910647
• NIH Device Record Key: f5ed4899-fcca-4b63-ab4a-40da04bac464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZhengKang
• Version Model Number: ZKM-U02 (Black)
• Company DUNS: 554549693
• Company Name: Guangzhou Zhengkang Medical Equipment Co., Ltd.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com
• Phone: +8602022036585
• Email: sale26@zkmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973824910630 [Primary]
GS1	06973824910647 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222204

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [ZhengKang]

• 06973824915680: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910746: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910722: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910708: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910685: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910661: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga
• 06973824910647: Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers aga