FDA.reportPublic FDA data

NitriSkin 150

Primary DI
00893257001865
Brand
NitriSkin 150
Company
Medgluv Inc.
Model
MG5391
Catalog number
MG5391
Device description
NitraSonic Nitrile Exam Gloves, Textured, Small
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
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893257001865PackageGS110In Commercial Distribution
00898110000504PrimaryGS10
00810145951903Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893257001865008932570018658932570018650893257001865
00898110000504008981100005048981100005040898110000504
00810145951903008101459519038101459519030810145951903

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
150
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
00850005229063NitraSoftMG5250MG52502023-10-31
00850005229070NitraSoftMG5251MG52512023-10-31
00850005229087NitraSoftMG5252MG52522023-10-31
00850005229094NitraSoftMG5253MG52532023-10-31
00850005229100NitraSoftMG5254MG52542023-10-31
00850005229117NitraSoftMG5255MG52552023-10-31
00850005229179NitraGrip 300MG5400MG54002023-10-31
00850005229186NitraGrip 300MG5401MG54012023-10-31
00850005229193NitraGrip 300MG5402MG54022023-10-31
00850005229209NitraGrip 300MG5403MG54032023-10-31
00850005229216NitraGrip 300MG5404MG54042023-10-31
00850005229230NitraPlusMG5450MG54502023-10-31
00893257001490NitraPlusMG5453MG54532023-10-31
00893257001902NitraPlusMG5451MG54512023-10-31
00893257001742OysterSkinMG5304MG53042023-10-31
00850005229285Black CobraMG59200MG592002023-10-31
00893257001896NitraPlusMG5452MG54522023-10-31
00850005229520AmethystMG5801MG58012023-10-31
00850005229537AmethystMG5802MG58022023-10-31
00850005229544AmethystMG5803MG58032023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20810132043714HCSConcordance Healthcare Solutions LLCQDO2026-01-30
20810132043721HCSConcordance Healthcare Solutions LLCQDO2026-01-30
00810094577964CuraplexBOUND TREE MEDICAL, LLCQDO2025-03-31
00810094577971CuraplexBOUND TREE MEDICAL, LLCQDO2025-03-31
20850061371021American Health and SafetyLabsource, Inc.QDO2025-03-27
20850061371038American Health and SafetyLabsource, Inc.QDO2025-03-27
00850020922413American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922424American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922431American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922444American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922455American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922994American Health and SafetyLabsource, Inc.QDO2024-12-13
20850045437477VirtueNephron Nitrile LLCQDO2024-12-02
00810094577797Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577803Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577827Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577841Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577858Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00304040186619Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
00304040186633Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10810132043373HCSConcordance Healthcare Solutions LLCQDO2024-09-27
00841277108330Sample Pack Velvet Nitrile Exam GloveSEMPERMED USA, INC.QDO2024-09-24
20860011916691DERMADELMedzah IndustriesQDO2024-07-22
20860011917407DERMADELMedzah IndustriesQDO2024-07-22
20850045437941Nephron NitrileNephron Nitrile LLCQDO2024-04-26
10810132043045HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043052HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043069HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043076HCSConcordance Healthcare Solutions LLCQDO2024-04-15
00304040179017Henry ScheinHENRY SCHEIN, INC.QDO2024-03-25