FlexGard

Basic Information

• Brand Name: FlexGard
• Primary DI: 00860010353219
• Version / Model: CRG-M-MTF
• Catalog Number: CRG-MTF-MTF
• Company Name: LDI Solutions, LLC
• Labeler DUNS: 175311088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-11
• Public Version: 1
• Public Version Date: 2024-04-19
• Public Version Status: New
• Public Device Record Key: f96b61f6-d80b-4afe-bea2-210bd8aafb48

Device Description

Cut resistant glove liners, sterile, size medium. (Packaged 10 pair/box. Invoiced by pair.)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18039	Glove liner	A cloth glove intended to be worn as a liner underneath rubber, plastic, or latex gloves (examination or surgical) to minimize the risk of allergic reactions, rashes, and other skin irritations, or to reduce the risk of sharps injuries. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010353219	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190782	000