FDA.reportPublic FDA data

Halyard

Primary DI
10809160542118
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
LCOD005-01
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103714000ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAAnsell Healthcare Products, LLC2011-07-07KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160542115PackageGS125In Commercial Distribution
10809160542118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054211520809160542115
1080916054211810809160542118

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160542019HALYARDDUGR84-012026-10-28
10809160542026HALYARDDUYV76-032026-10-28
10809160542033HALYARDDAHA30-022026-10-28
10809160542040HalyardDRRD93-012026-10-28
10809160542057HALYARDDUAV18-022026-10-28
10809160542064HalyardDUMD33-012026-10-28
10809160542071HalyardDUTC93-012026-10-28
10809160542088HalyardDAAU122026-10-28
10809160542095HALYARDDUMF13-022026-10-28
10809160542101HalyardDRNE38-022026-10-28
10809160542125HalyardSWDS0072026-10-28
10809160542132HalyardSWDS0062026-10-28
10809160542149HalyardDRPM81-012026-10-28
10809160542156HalyardWH0022-032026-10-28
10809160542170HalyardGUNH004-052026-10-28
10809160542187HalyardHWEX25-012026-10-28
10809160542194HalyardSCAV001-032026-10-28
10809160541784HALYARDDUTY24-022026-10-27
10809160541791HALYARDLLOF5109-052026-10-27
10809160541807HalyardDUNE88-012026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15