FDA.reportPublic FDA data

LOLA

Primary DI
10850038563155
Brand
LOLA
Company
FORUM BRANDS, LLC
Model
24CT Large (55mm) Ultra Thin Condoms
Device description
FRMBR1-LZ3-CW3SX
Published
2024-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896987000RUBBER CONDOM (NON-COLORED)Hankook Latex Gongup Co., Ltd.1990-06-06HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850038563155PackageGS124In Commercial Distribution
00850038563158PrimaryGS10
00851617007674Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003856315510850038563155
00850038563158008500385631588500385631580850038563158
00851617007674008516170076748516170076740851617007674

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

Regulatory Flags#

DUNS number
055659749
Device count
24
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
true
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
00810092259381LOLA12CT Large (55mm) Ultra Thin Condoms2024-08-29
00850038563158LOLA24CT Large (55mm) Ultra Thin Condoms2024-08-29
00810092259961LOLA8 CT SUPER NON-APPLICATOR TAMPONS2025-09-01
10810092259968LOLA8 CT SUPER NON-APPLICATOR TAMPONS2025-09-01
00810092259954LOLA 8 CT SUPER+ NON-APPLICATOR TAMPONS2025-08-15
10810092259951LOLA 8 CT SUPER+ NON-APPLICATOR TAMPONS2025-08-15
00850033446364LOLA8CT Light Compact Applicator Tampons2025-06-18
00850033446968LOLA8CT Regular Compact Applicator Tampons2025-06-18
00850038563134LOLA8CT Super Compact Applicator Tampons2025-06-18
00850038563141LOLA8CT Super + Compact Applicator Tampons2025-06-18
10850033446361LOLA8CT Light Compact Applicator Tampons2025-06-18
10850033446965LOLA8CT Regular Compact Applicator Tampons2025-06-18
10850038563131LOLA8CT Super Compact Applicator Tampons2025-06-18
10850038563148LOLA8CT Super + Compact Applicator Tampons2025-06-18
00851617007032LOLA28 count organic cotton ultra thin liners2020-04-28
10810092259388LOLA12CT Large (55mm) Ultra Thin Condoms2024-08-29
00851617007827LOLA24ct Ultra Thin Lubricated Condoms2020-06-30
00851617007339LOLA24ct Ultra Thin Lubricated Condoms2020-06-30
00851617007889LOLA12ct Ultra Thin Lubricated Condoms - .COM2020-03-04
00851617007049LOLA12 count organic cotton ultra thin pads w/wings2020-04-28

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