ZhengKang

GUDID 06973824915680

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.

Guangzhou Zhengkang Medical Equipment Co., Ltd.

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use

• Primary Device ID: 06973824915680
• NIH Device Record Key: 3a15494e-7d0d-46b0-8cf3-4a1c9e61a869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZhengKang
• Version Model Number: ZKM-U01
• 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: true
• 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: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com
• Phone: +8602032124239
• Email: info@zkmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973824915680 [Primary]
GS1	06973824915697 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212460

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: 2021-12-14
• Device Publish Date: 2021-12-06

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