FDA.reportPublic FDA data

NitraSoft

Primary DI
00850005229056
Brand
NitraSoft
Company
Medgluv Inc.
Model
MG5255
Catalog number
MG5255
Device description
NitraSoft Nitrile Exam Gloves, Cobalt Blue, Extra Extra Large
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove
LZCMedical Glove, Specialty
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005229117PackageGS110In Commercial Distribution
00850005229056PrimaryGS10
00810145951033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005229117008500052291178500052291170850005229117
00850005229056008500052290568500052290560850005229056
00810145951033008101459510338101459510330810145951033

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)633-4588sales@medgluv.com

Regulatory Flags#

DUNS number
015809044
Device count
230
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005229001NitraSoftMG5250MG52502023-10-31
00850005229018NitraSoftMG5251MG52512023-10-31
00850005229025NitraSoftMG5252MG52522023-10-31
00850005229032NitraSoftMG5253MG52532023-10-31
00850005229049NitraSoftMG5254MG52542023-10-31
00850005229124NitraGrip 300MG5400MG54002023-10-31
00850005229131NitraGrip 300MG5401MG54012023-10-31
00850005229148NitraGrip 300MG5402MG54022023-10-31
00850005229155NitraGrip 300MG5403MG54032023-10-31
00850005229162NitraGrip 300MG5404MG54042023-10-31
00850005229223NitraPlusMG5450MG54502023-10-31
00850005229254NitraPlusMG5453MG54532023-10-31
00850005229261NitraPlusMG5451MG54512023-10-31
00850005229278OysterSkinMG5304MG53042023-10-31
00850005229308Black CobraMG59200MG592002023-10-31
00850005229360NitraPlusMG5452MG54522023-10-31
00850005229483AmethystMG5801MG58012023-10-31
00850005229490AmethystMG5802MG58022023-10-31
00850005229506AmethystMG5803MG58032023-10-31
00850005229513AmethystMG5804MG58042023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04