FDA.reportPublic FDA data

NEXT-GEN

Primary DI
00810169610299
Brand
NEXT-GEN
Company
Genesee Scientific Holdings, LLC
Model
44-104XS
Catalog number
44-104XS
Device description
S-GEN Powder-Free Nitrile Examination Gloves, Size XS, 200
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810169610305PackageGS110In Commercial Distribution
00810169610299PrimaryGS10
10810169610296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810169610305008101696103058101696103050810169610305
00810169610299008101696102998101696102990810169610299
1081016961029610810169610296

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.

Regulatory Flags#

DUNS number
943016071
Device count
200
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169610312NEXT-GEN44-106L44-106L2026-07-06
00810169610336NEXT-GEN44-106M44-106M2026-07-06
00810169610350NEXT-GEN44-106S44-106S2026-07-06
00810169610374NEXT-GEN44-106XL44-106XL2026-07-06
00810169610398NEXT-GEN44-106XS44-106XS2026-07-06
00810169610114NEXT-GEN43-101L43-101L2026-04-27
00810169610138NEXT-GEN43-101M43-101M2026-04-27
00810169610152NEXT-GEN43-101S43-101S2026-04-27
00810169610176NEXT-GEN43-101XL43-101XL2026-04-27
00810169610190NEXT-GEN43-101XS43-101XS2026-04-27
00810169610213NEXT-GEN44-104L44-104L2026-04-27
00810169610237NEXT-GEN44-104M44-104M2026-04-27
00810169610251NEXT-GEN44-104S44-104S2026-04-27
00810169610275NEXT-GEN44-104XL44-104XL2026-04-27
00810169610015Genesee Scientific44-500L44-500L2026-02-26
00810169610039Genesee Scientific44-500M44-500M2026-02-26
00810169610053Genesee Scientific44-500S44-500S2026-02-26
00810169610077Genesee Scientific44-500XS44-500XS2026-02-26
00810169610091Genesee Scientific44-500XL44-500XL2026-02-26
00810169610022Genesee Scientific44-500L44-500L2026-02-26

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