FDA.reportPublic FDA data

NitraSoft

Primary DI
00850005229087
Brand
NitraSoft
Company
Medgluv Inc.
Model
MG5252
Catalog number
MG5252
Device description
NitraSoft Nitrile Exam Gloves, Cobalt Blue, Medium
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005229087PackageGS110In Commercial Distribution
00850005229025PrimaryGS10
00810145951002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005229087008500052290878500052290870850005229087
00850005229025008500052290258500052290250850005229025
00810145951002008101459510028101459510020810145951002

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
015809044
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810145951972NeuPro 16MG50171MG501712026-06-26
00810145951989NeuPro 16MG50172MG501722026-06-26
00810145951996NeuPro 16MG50173MG501732026-06-26
00810145952009NeuPro 16MG50174MG501742026-06-26
00810145952153NeulynxMG57505MG575052026-06-26
00850005229001NitraSoftMG5250MG52502023-10-31
00850005229018NitraSoftMG5251MG52512023-10-31
00850005229025NitraSoftMG5252MG52522023-10-31
00850005229032NitraSoftMG5253MG52532023-10-31
00850005229049NitraSoftMG5254MG52542023-10-31
00850005229056NitraSoftMG5255MG52552023-10-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00850069531256AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531263AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531270AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531287AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531294AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531300AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00810145951972NeuPro 16Medgluv Inc.LZC2026-06-26
00810145951989NeuPro 16Medgluv Inc.LZC2026-06-26
00810145951996NeuPro 16Medgluv Inc.LZC2026-06-26
00810145952009NeuPro 16Medgluv Inc.LZC2026-06-26
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21