FDA.reportPublic FDA data

PROMEDIX

Primary DI
04897147760326
Brand
PROMEDIX
Company
HONG KONG PROMEDIX COMPANY LIMITED
Model
PMD-HG5BLUE-M
Device description
Heavy Duty 5 Mil-100 Pcs-M,Blue,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician
Published
2025-07-10
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
04897147760371PackageGS120In Commercial Distribution
04897147760326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897147760371048971477603714897147760371
04897147760326048971477603264897147760326

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
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
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
04897147760029PROMEDIXPMD-HG6B-M2025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13