TGSS

GUDID 20850052497051

Black nitrile, M

Tony's Gloves & Safety Supply, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID20850052497051
NIH Device Record Key5e839698-ce4e-4a0b-8855-4b749866625f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTGSS
Version Model NumberTG1272M
Company DUNS055429269
Company NameTony's Gloves & Safety Supply, Inc.
Device Count100
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850052497057 [Primary]
GS110850052497054 [Package]
Package: [10 Units]
In Commercial Distribution
GS120850052497051 [Unit of Use]

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 Date2023-07-19
Device Publish Date2023-07-11