FDA.reportPublic FDA data

MICROFLEX

Primary DI
00683438529208
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
L920
Catalog number
L920
Device description
MICROFLEX L92X E-GRIP MAX SIZE XS (5.5-6.0), Latex 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
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00683438529208PackageGS110In Commercial Distribution
00683438129200PrimaryGS10
00071483002881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00683438529208006834385292086834385292080683438529208
00683438129200006834381292006834381292000683438129200
00071483002881000714830028810714830028810071483002881

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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
true
No natural rubber latex
false
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
D77116100LG0GuardianICP, INC.LYY2026-03-19
D77116100MD0GuardianICP, INC.LYY2026-03-19
D77116100SM0GuardianICP, INC.LYY2026-03-19
D77116100XL0GuardianICP, INC.LYY2026-03-19
D77116100XS0GuardianICP, INC.LYY2026-03-19
40080196762744MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762751MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762775MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
10888277703582MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
00810094090913ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090920ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090937ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090944ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090951ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
D1057115XS9MacTouch Surgimac LLCLYY2025-08-14
D1057115XSCS9MacTouch Surgimac LLCLYY2025-08-14
D1057116S9MacTouch Surgimac LLCLYY2025-08-14
D1057116SCS9MacTouch Surgimac LLCLYY2025-08-14
D1057117M9MacTouch Surgimac LLCLYY2025-08-14
D1057117MCS9MacTouch Surgimac LLCLYY2025-08-14
D1057118L9MacTouch Surgimac LLCLYY2025-08-14
D1057118LCS9MacTouch Surgimac LLCLYY2025-08-14
D1057119XL9MacTouch Surgimac LLCLYY2025-08-14
D1057119XLCS9MacTouch Surgimac LLCLYY2025-08-14
20742061700232KVPKVP International, Inc.LYY2025-08-12
20742061700249KVPKVP International, Inc.LYY2025-08-12
00742061700252KVPKVP International, Inc.LYY2025-08-12
20742061700263KVPKVP International, Inc.LYY2025-08-12
10076490456518TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
20076490001463TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30