CCW

GUDID 06973274100537

The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users’ mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.

Qinhuangdao Taizhi Medical Technology 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 Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 06973274100537
• NIH Device Record Key: c16c697d-7872-4d18-8b22-c66353b3953f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCW
• Version Model Number: Expanded chamber, Longitudinal fold, ear strap, 4
• Company DUNS: 715288182
• Company Name: Qinhuangdao Taizhi Medical Technology Co., Ltd.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973274100537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212205

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: 2021-11-12
• Device Publish Date: 2021-11-04

On-Brand Devices [CCW]

• 06973274100537: The mask materials include four layers, the inner and outer layers are made of spun-bond polypro
• 06973274100520: The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with e