FDA.reportPublic FDA data

GAMMEX

Primary DI
25414566642700
Brand
GAMMEX
Company
Ansell Healthcare Product
Model
340064070
Catalog number
340064070
Device description
GAMMEX® PI Ergo-Fit Size 7, Sterile Polyisoprene Powder-Free Surgical Glove
Published
2022-02-18
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
25414566642700PackageGS150In Commercial Distribution
35414566642707PackageGS14In Commercial Distribution
15414566642703PrimaryGS10
00071483001921Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2541456664270025414566642700
3541456664270735414566642707
1541456664270315414566642703
00071483001921000714830019210714830019210071483001921

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

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
00769799205019MICROFLEXEV-2050-XSEV-2050-XS2022-03-17
00769799205026MICROFLEXEV-2050-SEV-2050-S2022-03-17
00769799205033MICROFLEXEV-2050-MEV-2050-M2022-03-17
00769799205040MICROFLEXEV-2050-LEV-2050-L2022-03-17
00769799205057MICROFLEXEV-2050-XLEV-2050-XL2022-03-17
10076490788657MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
10076490788664MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
10076490788671MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
10076490788688MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
10076490788695MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
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
10076490456525TOUCHNTUFF69318070693180702025-07-30
10076490456532TOUCHNTUFF69318080693180802025-07-30
10076490456549TOUCHNTUFF69318090693180902025-07-30
10076490456556TOUCHNTUFF69318100693181002025-07-30
10076490456518TOUCHNTUFF69318060693180602025-07-30

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