DynaSafety Nitrile Gloves,X-Large,Non-Sterile

GUDID 00840117330764

DYNAREX CORPORATION

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00840117330764
NIH Device Record Keybfeaee83-0657-497a-81be-42a80d4b9307
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaSafety Nitrile Gloves,X-Large,Non-Sterile
Version Model Number2626UB-2
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count2
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810180840767 [Unit of Use]
GS100840117330764 [Package]
Contains: 00840117330771
Package: Case [100 Units]
In Commercial Distribution
GS100840117330771 [Primary]
GS108401173307712 [Unit of Use]

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 Date2024-05-27
Device Publish Date2024-05-17

Devices Manufactured by DYNAREX CORPORATION

00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g 2026-02-04
00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet2026-02-03
00840117348790 - Flavored Oral Swab, For Professional And Hospital use 2026-01-29 Individually Wrapped
00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use2026-01-29 Individually Wrapped
00840117348837 - Oral Swabsticks, Flavored w/Dentrifice2026-01-29
00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use2026-01-29
00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13
00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.