Amcon Nitrile Examination Gloves PD-7009-00000

GUDID 00351801020156

Large Amcon Nitrile Powder Free Examination Gloves

Nomax, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00351801020156
NIH Device Record Keyab75dcf0-664b-4f1e-9a74-07457401e308
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmcon Nitrile Examination Gloves
Version Model NumberNitrileLG
Catalog NumberPD-7009-00000
Company DUNS103220273
Company NameNomax, 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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com
Phone1-800-255-6161
Emailinfo@amconlabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100351801020149 [Primary]
GS100351801020156 [Package]
Contains: 00351801020149
Package: Case [10 Units]
In Commercial Distribution
GS100351801020200 [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 Date2026-01-23
Device Publish Date2026-01-15

On-Brand Devices [Amcon Nitrile Examination Gloves]

00351801020156Large Amcon Nitrile Powder Free Examination Gloves
00351801020132Medium Amcon Nitrile Powder Free Examination Gloves
00351801020118Small Amcon Nitrile Powder Free Examination Gloves

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