DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756906609
• Version / Model: 32-2086
• Catalog Number: 32-2086
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: d400a30b-724d-4ee0-b4be-c6d86840593e

Device Description

Large Cotton Gloves, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: Yes
• 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
LYU	ACCESSORY, SURGICAL APPAREL	General, Plastic Surgery	878.4040	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
Package	50749756906604	GS1	Case	50	In Commercial Distribution
Primary	00749756906609	GS1

Customer Contacts

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