FDA.reportPublic FDA data

LOLA

Primary DI
10810092259388
Brand
LOLA
Company
FORUM BRANDS, LLC
Model
12CT Large (55mm) Ultra Thin Condoms
Device description
FRMBR1-LZ3-C75SC
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
10810092259388PackageGS124In Commercial Distribution
00810092259381PrimaryGS10
00851617007674Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081009225938810810092259388
00810092259381008100922593818100922593810810092259381
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
12
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
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