OmniTrush 201-220

GUDID 50810572003546

Nitrile Examination Glove Powder Free X-Small

OMNI INTERNATIONAL CORP.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID50810572003546
NIH Device Record Keye7054518-51c0-47b6-ab8c-7916780f2312
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniTrush
Version Model Number201-220
Catalog Number201-220
Company DUNS079434709
Company NameOMNI INTERNATIONAL CORP.
Device Count200
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com
Phone603-471-1499
Emailinfo@omnigloves.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810572003541 [Primary]
GS110810572003548 [Unit of Use]
GS150810572003546 [Package]
Contains: 00810572003541
Package: Shipper Carton [10 Units]
In Commercial Distribution

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 Date2025-02-10
Device Publish Date2025-01-31

Devices Manufactured by OMNI INTERNATIONAL CORP.

50810572000439 - OmniTrust2025-02-10 Nitrile Examination Glove Powder Free XX-Large
50810572003485 - OmniTrust2025-02-10 Nitrile Examination Glove Powder Free X-Small
50810572003539 - OmniTrust2025-02-10 Nitrile Examination Glove Powder Free XX-Large
50810572003546 - OmniTrush2025-02-10Nitrile Examination Glove Powder Free X-Small
50810572003546 - OmniTrush2025-02-10 Nitrile Examination Glove Powder Free X-Small
50810572004550 - OmniTrust2024-07-31 OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF X-Small
50810572004567 - OmniTrust2024-07-30 OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Small
50810572004581 - OmniTrust2024-07-30 OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Large
50810572004574 - OmniTrust2024-07-30 OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Medium

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.