FDA.reportPublic FDA data

NEXT-GEN

Primary DI
00810169610237
Brand
NEXT-GEN
Company
Genesee Scientific Holdings, LLC
Model
44-104M
Catalog number
44-104M
Device description
S-GEN Powder-Free Nitrile Examination Gloves, Size M, 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
00810169610244PackageGS110In Commercial Distribution
00810169610237PrimaryGS10
10810169610234Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810169610244008101696102448101696102440810169610244
00810169610237008101696102378101696102370810169610237
1081016961023410810169610234

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
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
00810169610251NEXT-GEN44-104S44-104S2026-04-27
00810169610275NEXT-GEN44-104XL44-104XL2026-04-27
00810169610299NEXT-GEN44-104XS44-104XS2026-04-27
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
00810169610046Genesee Scientific44-500M44-500M2026-02-26
00810169610060Genesee Scientific44-500S44-500S2026-02-26
00810169610084Genesee Scientific44-500XS44-500XS2026-02-26
00810169610107Genesee Scientific44-500XL44-500XL2026-02-26
00850043811916Genesee Scientific44-500L44-500L2024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04