NWCS Medical Divison ArmorGuard

GUDID 00860010386460

New Wave Cleaning Solutions LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00860010386460
NIH Device Record Key28a0dbda-4444-457d-81d4-736d603730e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNWCS Medical Divison ArmorGuard
Version Model NumberNG-BLUE-LG
Company DUNS047495265
Company NameNew Wave Cleaning Solutions LLC
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 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
GS100860010386415 [Primary]
GS100860010386460 [Package]
Contains: 00860010386415
Package: Case [10 Units]
In Commercial Distribution
GS110860010386412 [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 Date2023-05-29
Device Publish Date2023-05-19

On-Brand Devices [NWCS Medical Divison ArmorGuard]

00860010386446NG-BLUE-SM
00860010386453NG-BLUE-MED
00860010386460NG-BLUE-LG
00860010386477NG_BLUE-XL

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