Specfit

Basic Information

• Brand Name: Specfit
• Primary DI: 00196852902323
• Version / Model: DN4MBL
• Company Name: Vallen Distribution, Inc.
• Labeler DUNS: 782807804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-29
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: a7713dea-9ec0-4e05-839c-71a163145d31

Device Description

Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, L

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: No
• Has Expiration Date: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
11885	Utility glove	A hand-worn device intended to be used by healthcare personnel to protect the hands from contamination and/or injury during paraclinical/non-clinical activities (e.g., handling waste, instrument reprocessing). It may be available in a variety of forms or with specific attributes (e.g., rubber, reinforced, heat resistant, with extended sleeve), however is not intended to protect from extreme cold/cryogenic temperatures (i.e., not a cryogenic safety glove). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00196852902323	GS1

Premarket Submissions

Submission Number	Supplement Number
K121526	000

Device Sizes

Type	Value	Unit	Text
Length	8	Millimeter
Length	2.25	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 45 Degrees Celsius