FDA.reportPublic FDA data

MICROFLEX

Primary DI
00683438542115
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
N211
Catalog number
N211
Device description
MICROFLEX N21X SIZE S, Nitrile 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
00683438542115PackageGS110In Commercial Distribution
00683438142117PrimaryGS10
00071483003093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00683438542115006834385421156834385421150683438542115
00683438142117006834381421176834381421170683438142117
00071483003093000714830030930714830030930071483003093

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 powder and it does not include antimicrobial agents/materials. 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 and comfort of use, and should provide 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975219206298RhesusZibo Blue Sail Innovation Co., Ltd.LZA2026-05-26
06975913080118ShengkunZibo Shengkun Chemical Industry Co., Ltd.LZA2026-05-26
00860015678935UCKER1ST TRY, CORPLZA2026-05-22
00860015678959UCKER1ST TRY, CORPLZA2026-05-22
00860015678966UCKER1ST TRY, CORPLZA2026-05-22
00860015678973UCKER1ST TRY, CORPLZA2026-05-22
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
00850006162215Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162192Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162222Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162239Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162246Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162185Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162178Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162161Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162154Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162147Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162130Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162352Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162369Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162376Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162345Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162321Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162314Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162307Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162048Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162031Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162024Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162017Posi-Prene GreenClinical Supply CompanyLZA2026-03-24