FDA.reportPublic FDA data

HALYARD

Primary DI
10680651190809
Brand
HALYARD
Company
Ansell
Model
SGL99080
Catalog number
SGL99080
Device description
HALYARD SGL99080 Polyisoprene Green Size (8.0), 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
20680651190806PackageGS150In Commercial Distribution
30680651190803PackageGS14In Commercial Distribution
10680651190809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068065119080620680651190806
3068065119080330680651190803
1068065119080910680651190809

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
775-746-6600nick.magri@ansell.com
775-470-7106don.cronk@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
10680651190656HALYARDSGL99065SGL990652024-07-12
10680651190700HALYARDSGL99070SGL990702024-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29