FDA.reportPublic FDA data

HALYARD

Primary DI
10680651190656
Brand
HALYARD
Company
Ansell
Model
SGL99065
Catalog number
SGL99065
Device description
HALYARD SGL99065 Polyisoprene Green Size (6.5), Powder-Free Polyisoprene Surgical Glove
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20680651190653PackageGS150In Commercial Distribution
30680651190650PackageGS14In Commercial Distribution
10680651190656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068065119065320680651190653
3068065119065030680651190650
1068065119065610680651190656

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene 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. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
775-470-7106don.cronk@ansell.com
775-746-6600nick.magri@ansell.com

Regulatory Flags#

DUNS number
120522524
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00076490718282HALYARDSGL85055BSGL85055B2024-07-19
00076490718299HALYARDSGL85060BSGL85060B2024-07-19
00076490718305HALYARDSGL85065BSGL85065B2024-07-19
00076490718312HALYARDSGL85070BSGL85070B2024-07-19
00076490718329HALYARDSGL85075BSGL85075B2024-07-19
00076490718336HALYARD SGL85080BSGL85080B2024-07-19
00076490718343HALYARDSGL85085BSGL85085B2024-07-19
00076490718350HALYARDSGL85090BSGL85090B2024-07-19
10076490705654HALYARDSGL85055BSGL85055B2024-07-19
10076490705661HALYARDSGL85060BSGL85060B2024-07-19
10076490705678HALYARDSGL85065BSGL85065B2024-07-19
10076490705685HALYARDSGL85070BSGL85070B2024-07-19
10076490705692HALYARDSGL85075BSGL85075B2024-07-19
10076490705708HALYARD SGL85080BSGL85080B2024-07-19
10076490705715HALYARDSGL85085BSGL85085B2024-07-19
10076490705722HALYARDSGL85090BSGL85090B2024-07-19
10680651190557HALYARDSGL99055SGL990552024-07-12
10680651190601HALYARDSGL99060SGL990602024-07-12
10680651190700HALYARDSGL99070SGL990702024-07-12
10680651190755HALYARDSGL99075SGL990752024-07-12

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Primary DI, Brand, Company table
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00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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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
00850069531157Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
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00850069531188Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
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10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
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