Trojan Enz Condom

Primary DI
80022600937520
Brand
Trojan Enz Condom
Company
CHURCH & DWIGHT CO., INC.
Model
00726893114036
Device description
Latex Condom: For Contraception Plus STI Protection.
Published
2020-03-11
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
HISCONDOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092586000
K901192000
K901194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092586000MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LUInnolatex (Thailand) Limited2010-05-12HIS
K901192000TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)Carter Products1990-04-16HIS
K901194000TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABELCarter Products1990-04-16HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00022600002321PrimaryGS10
00022600030454PrimaryGS10
00022600500001PrimaryGS10
00022600999485PrimaryGS10
00726893114036PrimaryGS10
00726893114104PrimaryGS10
00726893800021PrimaryGS10
80022600937520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600002321000226000023210226000023210022600002321
00022600030454000226000304540226000304540022600030454
00022600500001000226005000010226005000010022600500001
00022600999485000226009994850226009994850022600999485
00726893114036007268931140367268931140360726893114036
00726893114104007268931141047268931141040726893114104
00726893800021007268938000217268938000210726893800021
8002260093752080022600937520

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
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
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
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
00022600947219Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009472192016-10-14
00022600947325Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009473252016-10-13
00022600947400Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009474002016-10-13
00022600980506TROJAN™ NaturaLamb™ Luxury Condoms000226009805062016-10-13
00022600987536TROJAN™ NaturaLamb™ Luxury Condoms000226009875362016-10-13
00022600998440TROJAN™ NaturaLamb™ Luxury Condoms000226009984402016-10-13
00022600000600Trojan All The Feels Variety Pack000226000006002020-06-22
00022600000709Trojan All The Feels Variety Pack000226000007092020-07-29
00022600300007Trojan All the Feels Condom000226003000072020-06-10
00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
00726893114005Trojan Ultra Thin Condom007268931140052020-07-08
00726893114043Trojan Magnum007268931140432020-03-12
00726893114098Trojan Magnum Condom007268931140982020-03-27
00726893114104Trojan Enz007268931141042020-03-20
00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
00726893800038Trojan Mangum Condom007268938000382020-09-28
00022600019831TROJAN 100CT BULK MIX000226000198312018-10-30

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19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
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