FDA.reportPublic FDA data

HANX

Primary DI
05060703560428
Brand
HANX
Company
HANX LIMITED
Model
10 Pack Large Size
Device description
HANX Condoms, Large Size, Ultra-thin, Vegan, 10-pack.
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060703560428PackageGS16In Commercial Distribution
05060703560398PrimaryGS10
05060703560855Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060703560428050607035604285060703560428
05060703560398050607035603985060703560398
05060703560855050607035608555060703560855

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length195Millimeter
Width56Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place away from direct sunlight and heat

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221266506
Device count
10
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
true
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
05060703560381HANX10 Pack Standard Size2024-01-05
05060703560398HANX10 Pack Large Size2024-01-05
05060703560596HANX3 Pack Standard Size2024-01-05
05060703560374HANX1 Pack Standard Size2024-01-05
05060703560411HANX10 Pack Standard Size2024-01-05
05060703560619HANX3 Pack Standard Size2024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120747One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107383LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20