FDA.report

GAMMEX

Primary DI
25414566690602
Brand
GAMMEX
Company
Ansell Healthcare Product
Model
340069060
Catalog number
340069060
Device description
GAMMEX® PI Glove-in-Glove™ System Half Size Larger Size 6, 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

Related Records

Contact Domains

Product Codes

CodeName
KGOSurgeon'S Gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
25414566690602PackageGS125In Commercial Distribution
35414566690609PackageGS14In Commercial Distribution
15414566690605PrimaryGS10
00071483001679Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2541456669060225414566690602
3541456669060935414566690609
1541456669060515414566690605
00071483001679000714830016790714830016790071483001679

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

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20076490793184MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
20076490793191MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
20076490793207MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
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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

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