FDA.reportPublic FDA data

Empire

Primary DI
00850030415516
Brand
Empire
Company
Empire Managed Solutions LLC
Model
5.5 MIL Nitrile Gloves- Box
Published
2023-07-14
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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030415516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030415516008500304155168500304155160850030415516

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117334642
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030415431Empire5.5 MIL Nitrile Gloves- Case2023-07-14
00850030415448Empire5.5 MIL Nitrile Gloves- Case2023-07-14
00850030415455Empire5.5 MIL Nitrile Gloves- Case2023-07-14
00850030415462Empire5.5 MIL Nitrile Gloves- Case2023-07-14
00850030415479Empire4 MIL Nitrile Gloves- Case2023-07-14
00850030415486Empire4 MIL Nitrile Gloves- Case2023-07-14
00850030415523Empire5.5 MIL Nitrile Gloves- Box2023-07-14
00850030415530Empire5 MIL Nitrile Gloves- Box2023-07-14
00850030415547Empire4 MIL Nitrile Gloves- Box2023-07-14
00850030415493Empire5.5 MIL Nitrile Gloves- Box2023-07-13
00850030415509Empire5.5 MIL Nitrile Gloves- Box2023-07-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
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00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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