FDA.report

MICROFLEX

Primary DI
00769799288081
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
NEC-288-L
Catalog number
NEC-288-L
Device description
MICROFLEX NEC-288 NEOPRO EC SIZE L (8.5-9.0), Neoprene Powder-Free Examination Glove
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00769799288081PackageGS110In Commercial Distribution
00769799288180PrimaryGS10
00071483003581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00769799288081007697992880817697992880810769799288081
00769799288180007697992881807697992881800769799288180
00071483003581000714830035810714830035810071483003581

GMDN Terms

TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags

DUNS number
111267330
Device count
50
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
false
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 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
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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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