FDA.reportPublic FDA data

HALYARD

Primary DI
10076490705715
Brand
HALYARD
Company
Ansell
Model
SGL85085B
Catalog number
SGL85085B
Device description
Halyard SGL85085B HALYARD Neoprene Micro Bulk Size (8.5), Powder-Free Neoprene Surgical Glove
Published
2024-07-19
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
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10076490705715PackageGS150In Commercial Distribution
20076490718538PackageGS14In Commercial Distribution
00076490718343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007649070571510076490705715
2007649071853820076490718538
00076490718343000764907183430764907183430076490718343

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene surgical glove, non-powderedA device made of polychloroprene (neoprene) 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120522524
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10076490705722HALYARDSGL85090BSGL85090B2024-07-19
10680651190557HALYARDSGL99055SGL990552024-07-12
10680651190601HALYARDSGL99060SGL990602024-07-12
10680651190656HALYARDSGL99065SGL990652024-07-12
10680651190700HALYARDSGL99070SGL990702024-07-12
10680651190755HALYARDSGL99075SGL990752024-07-12

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