FDA.reportPublic FDA data

MICROFLEX

Primary DI
00683438535230
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
C523
Catalog number
C523
Device description
MICROFLEX C52X NEOGARD 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00683438535230PackageGS110In Commercial Distribution
00683438135232PrimaryGS10
00071483002485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00683438535230006834385352306834385352300683438535230
00683438135232006834381352326834381352320683438135232
00071483002485000714830024850714830024850071483002485

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
111267330
Device count
100
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 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

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10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
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