ClearMask

Basic Information

• Brand Name: ClearMask
• Primary DI: 00860005106028
• Version / Model: v1.0
• Company Name: Clearmask, LLC
• Labeler DUNS: 080991401
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2020-11-20
• Public Version: 1
• Public Version Date: 2020-11-30
• Public Version Status: New
• Public Device Record Key: 8c176c7d-f577-4bdd-9bbc-295ace2cb365

Device Description

Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided 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: 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
35177	Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860005106025	GS1	Case	18	In Commercial Distribution
Primary	00860005106028	GS1
Package	20860005106022	GS1	Pallet	16	In Commercial Distribution
Unit of Use	00860005106035	GS1

Premarket Submissions

Submission Number	Supplement Number
K200576	000