FDA.reportPublic FDA data

NEXT-GEN

Primary DI
00850043811831
Brand
NEXT-GEN
Company
Genesee Scientific Holdings, LLC
Model
44-100MBK
Catalog number
44-100MBK
Device description
X-GEN Powder-Free Nitrile Examination Gloves, Size M, Black, 100
Published
2024-04-16
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043811848PackageGS110In Commercial Distribution
00850043811831PrimaryGS10
10850043811838Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043811848008500438118488500438118480850043811848
00850043811831008500438118318500438118310850043811831
1085004381183810850043811838

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
100
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956202558Body GuardFastenal CompanyLZA2026-09-30
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00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
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00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03