FDA.reportPublic FDA data

MICROFLEX

Primary DI
00769799325014
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
SEC-375-3XL
Catalog number
SEC-375-3XL
Device description
MICROFLEX SEC-375 SUPRENO EC SIZE 3XL (11.5-12.0), 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
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00769799325113PackageGS110In Commercial Distribution
00769799325014PrimaryGS10
00071483003734Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00769799325113007697993251137697993251130769799325113
00769799325014007697993250147697993250140769799325014
00071483003734000714830037340714830037340071483003734

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.

Contacts#

Phone, Email table
PhoneEmail
775-746-6600jacob.ramirez@ansell.com
775-470-7106don.cronk@ansell.com

Regulatory Flags#

DUNS number
111267330
Device count
40
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00769799205019MICROFLEXEV-2050-XSEV-2050-XS2022-03-17
00769799205026MICROFLEXEV-2050-SEV-2050-S2022-03-17
00769799205033MICROFLEXEV-2050-MEV-2050-M2022-03-17
00769799205040MICROFLEXEV-2050-LEV-2050-L2022-03-17
00769799205057MICROFLEXEV-2050-XLEV-2050-XL2022-03-17
10076490788657MICROFLEXXC-310CP-XSXC-310CP-XS2025-08-05
10076490788664MICROFLEX XC-310CP-SXC-310CP-S2025-08-05
10076490788671MICROFLEXXC-310CP-MXC-310CP-M2025-08-05
10076490788688MICROFLEXXC-310CP-LXC-310CP-L2025-08-05
10076490788695MICROFLEXXC-310CP-XLXC-310CP-XL2025-08-05
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
10076490456525TOUCHNTUFF69318070693180702025-07-30
10076490456532TOUCHNTUFF69318080693180802025-07-30
10076490456549TOUCHNTUFF69318090693180902025-07-30
10076490456556TOUCHNTUFF69318100693181002025-07-30
10076490456518TOUCHNTUFF69318060693180602025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04