FDA.reportPublic FDA data

Halyard

Primary DI
10680651483642
Brand
Halyard
Company
Avanos Medical, Inc.
Model
48364
Catalog number
48364
Device description
SFESKN,Nitrile,Exam Glove,LAV,MD,50
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K081260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081260000KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVESKimberly-Clark Corp.2008-07-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20680651483649PackageGS14In Commercial Distribution
30680651483646PackageGS110In Commercial Distribution
10680651483642PrimaryGS10
90680651483648Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068065148364920680651483649
3068065148364630680651483646
1068065148364210680651483642
9068065148364890680651483648

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.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
079375431
Device count
50
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
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
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
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