FDA.reportPublic FDA data

ONE Super Sensitive

Primary DI
10726893112046
Brand
ONE Super Sensitive
Company
GLOBAL PROTECTION CORP.
Model
11602
Device description
12 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
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10726893112046PackageGS13In Commercial Distribution
20726893112043PackageGS124In Commercial Distribution
00726893112049PrimaryGS10
80726893111857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072689311204610726893112046
2072689311204320726893112043
00726893112049007268931120497268931120490726893112049
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
12
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
20726893120680One Classic Select11000BC2026-04-28
20726893120697One Flavorwaves110200BC2026-04-28
20726893120703One Legend11400BC2026-04-28
20726893120468One Ultra Feel112309C2026-04-24
20726893120475One Flex1131009C2026-04-24
20726893120499One Super Studs111709C2026-04-24
20726893120505One Vanish111309C2026-04-24
20726893120512One Pleasure Plus110309C2026-04-24
20726893120529One Super Sensitive11609C2026-04-24
20726893120536ONE Flavorwaves110209C2026-04-24
20726893120543One Legend11409C2026-04-24
20726893120550One Tattoo Touch112009C2026-04-24
20726893120567One Glowing Pleasures11509C2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893114432ONE Backdoor PackGLOBAL PROTECTION CORP.QRZ2023-04-07
10726893114439ONE Backdoor PackGLOBAL PROTECTION CORP.QRZ2023-04-07
00726893111301ONE Vanish HyperthinGLOBAL PROTECTION CORP.QRZ2020-06-15
00726893111950One Vanish HyperthinGLOBAL PROTECTION CORP.QRZ2020-06-15
10726893111308ONE Vanish HyperthinGLOBAL PROTECTION CORP.QRZ2020-06-15
20726893111954One Vanish HyperthinGLOBAL PROTECTION CORP.QRZ2020-06-15
20726893111770ONE Classic Select Artist CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
20726893111787ONE Classic Select MSM CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
20726893111794ONE Classic Select Contest CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
20726893111800ONE Classic Select Urban CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
80726893111772ONE Classic Select Artist CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
80726893111789ONE Classic Select MSM CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
80726893111796ONE Classic Select Contest CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
80726893111802ONE Classic Select Urban CollectionGLOBAL PROTECTION CORP.QRZ2020-06-02
00726893112049ONE Super SensitiveGLOBAL PROTECTION CORP.QRZ2020-06-01
00726893116030ONE Super SensitiveGLOBAL PROTECTION CORP.QRZ2020-06-01
10726893116037ONE Super SensitiveGLOBAL PROTECTION CORP.QRZ2020-06-01
20726893111855ONE Super SensitiveGLOBAL PROTECTION CORP.QRZ2020-06-01