FDA.reportPublic FDA data

NitriSkin Pairs

Primary DI
00898110000177
Brand
NitriSkin Pairs
Company
Medgluv Inc.
Model
MGSE552L
Catalog number
MGSE552L
Device description
NitriSkin Nitrile Exam Gloves, Sterile Pairs, Large
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898110000177PackageGS14In Commercial Distribution
00898110000085PrimaryGS10
00810145951828Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898110000177008981100001778981100001770898110000177
00898110000085008981100000858981100000850898110000085
00810145951828008101459518288101459518280810145951828

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
50
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
true
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

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Primary DI, Brand, Company table
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00860015678973UCKER1ST TRY, CORPLZA2026-05-22
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
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