FDA.reportPublic FDA data

Sterigluv Singles

Primary DI
00898110000580
Brand
Sterigluv Singles
Company
Medgluv Inc.
Model
MGSE100M
Catalog number
MGSE100M
Device description
Sterigluv Latex Exam Gloves, Sterile Singles, 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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex patient examination glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898110000580PackageGS14In Commercial Distribution
00898110000412PrimaryGS10
00810145951699Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898110000580008981100005808981100005800898110000580
00898110000412008981100004128981100004120898110000412
00810145951699008101459516998101459516990810145951699

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
100
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
true
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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