FDA.reportPublic FDA data

ID Condoms

Primary DI
00761236110245
Brand
ID Condoms
Company
WESTRIDGE LABORATORIES INCORPORATED
Model
ID Extra Large (Bag/144)
Catalog number
IDDCXLB0
Device description
A premium lubricated latex condom
Published
2017-02-09
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910284000CONDOMS (RUBBER CONTRACEPTIVES)Suretex, Ltd.1991-06-04HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761236110245PrimaryGS10
00761236110252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761236110245007612361102457612361102450761236110245
00761236110252007612361102527612361102520761236110252

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
17142599400service@westridgelabs.com

Regulatory Flags#

DUNS number
879057065
Device count
144
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
00195893640959Analcaine Kick Ass Lube WB 4ozAnalcaine Kick Ass Lube WB 4ozIDD115262023-04-12
00651277000691Travel Assets 7.5ml Foil Water Based Cock OilTravel Assets 7.5ml Foil Water Based Cock OilIDD11A002023-04-12
00850013816040CHAMP 4.4 fl oz Water Based BottleCHAMP 4.4 fl oz Water Based BottleIDD113952023-04-24
00850013816057CHAMP 1 fl oz Water Based BottleCHAMP 1 fl oz Water Based BottleIDD113942023-04-24
00858291006061Obsess Me Water Based Lubricant 16 ozObsess Me Water Based Lubricant 16 oz2023-04-12
00858291006054Obsess Me Water Based Lubricant 8.5 ozObsess Me Water Based Lubricant 8.5 oz2023-04-12
00858291006078Obsess Me Water Based Lubricant 32 ozObsess Me Water Based Lubricant 32 ozIDD11B032023-04-12
00858291006085Obsess Me Toy Cleaner Bottle 8.1ozObsess Me Toy Cleaner Bottle 8.1ozIDD11B042023-04-25
00761236902604FAVFAV 33.5 fl oz WB BottleIDD200022026-02-11
00761236903571FAVFAV 12oz Anal LubricantIDD200042026-02-11
00761236902598FAV8.25 fl oz WB BottleIDD200012026-02-09
90761236902591FAV8.25 fl oz WB BottleIDD200012026-02-09
00761236903427ID Totally NakedID Totally Naked 4ml FoilIDDFNF04AA2025-10-29
00761236903274ID Sex GreaseID Sex Grease 4.4oz Water BasedIDDGTB04AA2025-10-28
00761236903281ID Sex GreaseSex Grease 8.5 fl oz Water BasedIDDGTB08AA2025-10-28
00761236903298ID Sex GreaseID Seax Grease 4.4 fl oz Silicone BasedIDDGSB04AA2025-10-28
00761236903311ID Sex GreaseSex Grease 8.5 fl oz Silicone BasedIDDGSB08AA2025-10-28
00761236903403ID SensationID Sensation 4 ml FoilIDDSEF04AA2025-10-28
00761236904035ID Toy LubeID Toy Lube 4.4oz IDDWTL04AA2025-10-28
00761236903267ID Sex GreaseID Sex Grease 4 ml Foil Water BasedIDDGTF04AA2025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
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
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18