FDA.reportPublic FDA data

ONE Super Sensitive

Primary DI
00726893116030
Brand
ONE Super Sensitive
Company
GLOBAL PROTECTION CORP.
Model
11603
Device description
3 Lubricated male Latex Condoms
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom
QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
QRZExternal Condom For Anal Intercourse Or Vaginal IntercourseObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10726893116037PackageGS16In Commercial Distribution
20726893116034PackageGS124In Commercial Distribution
00726893116030PrimaryGS10
80726893111857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072689311603710726893116037
2072689311603420726893116034
00726893116030007268931160307268931160300726893116030
8072689311185780726893111857

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.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
3
DM exempt
true
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
06977708239688ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239695ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239701ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239718ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
00860014891533HUNKHunk World, Inc.HIS2026-08-19
00860014891540HUNKHunk World, Inc.HIS2026-08-19
00860014891557HUNKHunk World, Inc.HIS2026-08-19
08852961028959Lelo Hex Lubricated Natural Rubber Latex Condom 36’sLeloi ABHIS2026-07-27
08852961028935Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-07-22
08852961028942Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-07-22
06936296747371Male Latex CondomsShanghai Personage Hygiene Products Co.,Ltd.HIS2026-06-26
08852961033205Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 packLeloi ABHIS2026-06-25
08852961033212Lelo Hex Lubricated Natural Rubber Latex Condom collection 12 packLeloi ABHIS2026-06-25
08859798108960LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
08859798108977LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-06-25
06925634004245RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004252RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004269RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004276RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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