FDA.reportPublic FDA data

GAMMEX

Primary DI
25414566842858
Brand
GAMMEX
Company
Ansell Healthcare Product
Model
340084085
Catalog number
340084085
Device description
GAMMEX® PI Glove-in-Glove™ System Size 8.5, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove
Published
2022-02-16
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

Contact Domains#

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
25414566842858PackageGS150In Commercial Distribution
35414566842855PackageGS14In Commercial Distribution
15414566842851PrimaryGS10
00071483001792Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2541456684285825414566842858
3541456684285535414566842855
1541456684285115414566842851
00071483001792000714830017920714830017920071483001792

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene surgical glove, non-powderedA sterile 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 talcum powder and it does not have antimicrobial features. 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

Contacts#

Phone, Email table
PhoneEmail
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags#

DUNS number
111267330
Device count
2
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
20076490793160MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
20076490793177MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
20076490793184MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
20076490793191MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
20076490793207MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
10076490456518TOUCHNTUFF69318060693180602025-07-30
20076490001463TOUCHNTUFF69318070693180702025-07-30
20076490001470TOUCHNTUFF69318080693180802025-07-30
20076490001487TOUCHNTUFF69318090693180902025-07-30
20076490001494TOUCHNTUFF69318100693181002025-07-30
20076490721248KIMTECH62760627602025-07-21
20076490727141KIMTECH62761627612025-07-21
20076490729312KIMTECH62764627642025-07-21
20076490736495KIMTECH62763627632025-07-21
20076490750088KIMTECH62762627622025-07-21
20076490724171KIMTECH50602506022025-07-03
20076490730592KIMTECH50709507092025-07-03
20076490748658KIMTECH55090550902025-07-03
20076490750262KIMTECH50604506042025-07-03
20076490754888KIMTECH50706507062025-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07323190091171Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091218Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091263Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091300Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091348Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091379Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091454Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
00841277110791Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110807Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110814Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110821Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110838Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110845Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110852Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
00841277110869Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
30888277347902MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
30888277347926MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-02
30080196307504MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40080196307525MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40080196307549MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20080196417305MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
40888277347916MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277347933MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417124MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417131MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417148MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417158MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417162MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
20888277417172MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01
30888277417186MEDLINEMEDLINE INDUSTRIES, INC.KGO2025-12-01