NitriDerm®

Basic Information

• Brand Name: NitriDerm®
• Primary DI: 20813172024231
• Version / Model: 135285
• Company Name: INNOVATIVE HEALTHCARE CORPORATION
• Labeler DUNS: 802020693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 8f9e61f3-5ee1-4a99-b33c-0b1ce7a15d73

Device Description

Gloves, Surgical, Nitrile, Chemo Powder-Free, Textured, 8.5

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
LZC	Patient Examination Glove, Specialty	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56291	Nitrile surgical glove, non-powdered	A sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813172024234	GS1	50 pr/bx, 4 bx/cs	4	In Commercial Distribution
Primary	20813172024231	GS1
Unit of Use	00813172024237	GS1