SafeTouch Sterile Latex Surgical Gloves, 7.0

GUDID 00616784237015

Sterile-EO, Powder-Free / Cuffed

Dynarex Corporation

Hevea-latex surgical glove, non-powdered, non-antimicrobial
Primary Device ID00616784237015
NIH Device Record Keyb5d92003-b5da-444a-b1dd-6567de8704a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeTouch Sterile Latex Surgical Gloves, 7.0
Version Model Number2370
Company DUNS008124539
Company NameDynarex Corporation
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784237015 [Primary]
GS100616784237022 [Package]
Package: Box [50 Units]
In Commercial Distribution
GS100616784237039 [Package]
Contains: 00616784237022
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGOSurgeon'S Gloves

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

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