Specfit

GUDID 00196852952410

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

Vallen Distribution, Inc.

Utility glove
Primary Device ID00196852952410
NIH Device Record Keya930177a-f55f-4cf8-b7d8-13c3e92771a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecfit
Version Model NumberDN4MBM
Company DUNS782807804
Company NameVallen Distribution, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter
Length8 Millimeter
Length2.25 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100196852952410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-09-29

On-Brand Devices [Specfit]

00196852952410Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, M
00196852902323Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, L
00196852445684Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, S
00196852240364Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, XL

Trademark Results [Specfit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPECFIT
SPECFIT
97752035 not registered Live/Pending
Wheel Pros, LLC
2023-01-12
SPECFIT
SPECFIT
88618202 not registered Live/Pending
Sonepar Management US, Inc.
2019-09-16
SPECFIT
SPECFIT
78721956 3287874 Dead/Cancelled
Risso, Mark S.
2005-09-28

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