FDA.reportPublic FDA data

Jet Black Supply

Primary DI
00630148904924
Brand
Jet Black Supply
Company
Nexus Brands Group, Inc.
Model
JBS-35G-NGL
Device description
Individual box, LARGE
Published
2024-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213843000Nitrile Examination GlovesDong Tai City Huayi Gloves Co., Ltd.2022-03-31LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630148663838PackageGS110In Commercial Distribution
00630148904924PrimaryGS10
03630148904921Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630148663838006301486638386301486638380630148663838
00630148904924006301489049246301489049240630148904924
03630148904921036301489049213630148904921

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
045458013
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630148904900Jet Black SupplyJBS-35G-NGS2024-05-31
00630148904917Jet Black SupplyJBS-35G-NGM2024-05-31
00630148904931Jet Black SupplyJBS-35G-XLARGE2024-05-31
00630148663814Jet Black SupplyJBS-35G-NGS2024-05-31
00630148663821Jet Black SupplyJBS-35G-NGM2024-05-31
00630148663838Jet Black SupplyJBS-35G-NGL2024-05-31
03630148904938Jet Black SupplyJBS-35G-XLARGE2024-05-31

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Primary DI, Brand, Company table
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00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
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10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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00810145952115NeuleafMedgluv Inc.LZA2026-06-30
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00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29