Open Palm Mitt

Basic Information

• Brand Name: Open Palm Mitt
• Primary DI: G031104OPMRL0
• Version / Model: 104OPMRL
• Company Name: Shielding International Inc.
• Labeler DUNS: 009647322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 4df1cd78-0ab2-4960-a088-01605fe84b01

Device Description

Open Palm Vet MItt shields back of hand. features hook & loop wrist strap and elastic loops to secure fingers 0.5mm Regular Lead

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWP	Radiographic Protective Glove	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38365	Radiation-shielding procedure preparation glove/mitten	A personal protective device intended to be used to shield the entire hand or hands of medical personnel from unnecessary exposure to primary and scattered radiation associated with the preparation of a diagnostic and/or therapeutic radiological procedure (e.g., patient positioning). It is typically intended for procedure set-up or patient positioning; it is not a patient examination/treatment glove, nor a surgical glove. It typically includes a thin layer of lead (Pb) or lead-equivalent material and may be fluid resistant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G031104OPMRL0	HIBCC