FDA.reportPublic FDA data

LOLA

Primary DI
00850038563158
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K081265000
K896987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081265000THAI NIPPON MALE LATEX CONDOMThai Nippon Rubber Industry Co., Ltd.2009-10-16HIS
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.

Regulatory Flags#

DUNS number
055659749
Device count
24
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810092259381LOLA12CT 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
10850038563155LOLA24CT 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
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