FDA.reportPublic FDA data

Custom Condoms

Primary DI
00726893118416
Brand
Custom Condoms
Company
GLOBAL PROTECTION CORP.
Model
PP24-CKIT
Device description
custom kit for Planned Parenthood, bag of 500
Published
2025-01-06
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
HISCondom
MOLCondom, Synthetic
MSCBarrier, Std, Oral Sex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
MOLCondom, SyntheticObstetrics/Gynecology2
MSCBarrier, Std, Oral SexObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00726893118416PrimaryGS10
80726893118412Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00726893118416007268931184167268931184160726893118416
8072689311841280726893118412

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
500
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00726893120365One Lux11320062026-06-08
00726893120594Harmony Latex DamPHA202R2026-06-08
00726893120600harmony Non- Latex damsPHA101U2026-06-08
00726893120617Harmony Latex DamsPHA202U2026-06-08
00726893120730One Lux11330062026-06-08
00726893120747One Lux11340062026-06-08
00726893120778One Unity Collection11600BY2026-06-08
00726893120945One Lux113200B2026-06-08
00726893120952One Lux113300B2026-06-08
00726893120969One Lux113400B2026-06-08
00810124865085Adam and Eve hard rider99PHE200C2026-06-08
00860015576620Swoon Ultra Thin99SWON2022026-06-08
10860015576603Swoon Ultra Thin99SWON200C2026-06-08
00726893120587Harmony non-Latex DamPHA101R2026-06-04
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120594Harmony Latex DamGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120600harmony Non- Latex damsGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120617Harmony Latex DamsGLOBAL PROTECTION CORP.MSC2026-06-08
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
00726893120587Harmony non-Latex DamGLOBAL PROTECTION CORP.MSC2026-06-04
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
00302340996136Durex IntenseRECKITT BENCKISER LLCMOL2026-03-02
00302340995825Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340995993Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996006Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996013Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340996020Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340096584DUREX Intense Sensation CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340300452DUREX Classic CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340995696DUREX® Adventure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340300421DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340989336DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20