N-Dex

Basic Information

• Brand Name: N-Dex
• Primary DI: 00038054686406
• Version / Model: XL
• Catalog Number: M7005PFXL
• Company Name: SHOWA BEST GLOVE, INC.
• Labeler DUNS: 807930412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-02-20
• Public Version: 1
• Public Version Date: 2023-02-28
• Public Version Status: New
• Public Device Record Key: 8707f25a-0f6c-4d21-8ac7-2f1e3c9569c5

Device Description

Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/Extra Large

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: Yes
• Has Manufacturing Date: Yes
• 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
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1
LZC	Patient Examination Glove, Specialty	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56286	Nitrile examination/treatment glove, non-powdered, non-antimicrobial	A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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	20038054686400	GS1		20	In Commercial Distribution
Primary	00038054686406	GS1
Unit of Use	10038054686403	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211003	000