FDA.reportPublic FDA data

NitraSoft

Primary DI
00850005229018
Brand
NitraSoft
Company
Medgluv Inc.
Model
MG5251
Catalog number
MG5251
Device description
NitraSoft Nitrile Exam Gloves, Cobalt Blue, Small
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
00850005229070PackageGS110In Commercial Distribution
00850005229018PrimaryGS10
00810145950999Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005229070008500052290708500052290700850005229070
00850005229018008500052290188500052290180850005229018
00810145950999008101459509998101459509990810145950999

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
250
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810145950975NeuMask PinkMGM103MGM1032026-07-17
00850005229728NeuMask OrangeMGM102MGM1022026-07-17
00850005229803NeulynxMG57500MG575002026-07-17
00850005229810NeulynxMG57501MG575012026-07-17
00850005229827NeulynxMG57502MG575022026-07-17
00850005229834NeulynxMG57503MG575032026-07-17
00850005229841NeulynxMG57504MG575042026-07-17
00810145952054NeuSkin ClearMG3000MG30002026-06-29
00810145952061NeuSkin ClearMG3001MG30012026-06-29
00810145952078NeuSkin ClearMG3002MG30022026-06-29
00810145952085NeuSkin ClearMG3003MG30032026-06-29
00810145952092NeuSkin ClearMG3004MG30042026-06-29
00810145952108NeuleafMG57700MG577002026-06-29
00810145952115NeuleafMG57701MG577012026-06-30
00810145952122NeuleafMG57702MG577022026-06-30
00810145952139NeuleafMG57703MG577032026-06-30
00810145952146NeuleafMG57704MG577042026-06-30
00810145952429NitraGrip Pro 100MG5009XP1MG5009XP12026-06-30
00810145952436NitraGrip Pro 100MG5009XP2MG5009XP22026-06-30
00810145952443NitraGrip Pro 100MG5009XP3MG5009XP32026-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229803NeulynxMedgluv Inc.QDO2026-07-17