FDA.reportPublic FDA data

NOVAPLUS

Primary DI
20014566500557
Brand
NOVAPLUS
Company
Ansell Healthcare Product
Model
V20685955
Catalog number
V20685955
Device description
NOVAPLUS® GAMMEX® Non-Latex PI Micro Size 5.5, Sterile Polyisoprene Powder-Free Surgical Glove
Published
2022-03-10
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
20014566500557PackageGS150In Commercial Distribution
30014566500554PackageGS14In Commercial Distribution
10014566500550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2001456650055720014566500557
3001456650055430014566500554
1001456650055010014566500550

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
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
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
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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
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