FDA.reportPublic FDA data

PROMEDIX

Primary DI
04897147760098
Brand
PROMEDIX
Company
HONG KONG PROMEDIX COMPANY LIMITED
Model
PMD-HG5B-XL
Device description
Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-XL,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
Published
2025-06-26
Public version status
Update
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
K123869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123869000POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESDehai (Shandong) Medical Gloves, Co., Ltd.2013-02-28LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897147760142PackageGS120In Commercial Distribution
04897147760098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897147760142048971477601424897147760142
04897147760098048971477600984897147760098

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
663245238
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897147760494PROMEDIXPMD-HG6B-S 10002026-02-27
04897147760500PROMEDIXPMD-HG6B-M 10002026-02-27
04897147760517PROMEDIXPMD-HG6B-L 10002026-02-27
04897147760524PROMEDIXPMD-HG6B-XL 10002026-02-27
04897147760531PROMEDIXPMD-HG6B-XXL 10002026-02-27
04897147760210PROMEDIXPMD-HG6BLUE-S2025-07-07
04897147760227PROMEDIXPMD-HG6BLUE-M2025-07-07
04897147760234PROMEDIXPMD-HG6BLUE-L2025-07-07
04897147760241PROMEDIXPMD-HG6BLUE-XL2025-07-07
04897147760258PROMEDIXPMD-HG6BLUE-XXL2025-07-07
04897147760319PROMEDIXPMD-HG5BLUE-S2025-07-10
04897147760326PROMEDIXPMD-HG5BLUE-M2025-07-10
04897147760333PROMEDIXPMD-HG5BLUE-L2025-07-10
04897147760340PROMEDIXPMD-HG5BLUE-XL2025-07-10
04897147760357PROMEDIXPMD-HG5BLUE-XXL2025-07-10
04897147760418PROMEDIXPMD-4CB-S2025-07-17
04897147760425PROMEDIXPMD-4CB-M2025-07-17
04897147760432PROMEDIXPMD-4CB-L2025-07-17
04897147760449PROMEDIXPMD-4CB-XL2025-07-17
04897147760012PROMEDIXPMD-HG6B-S2025-06-26

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Primary DI, Brand, Company table
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00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
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
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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