FDA.reportPublic FDA data

LOLA

Primary DI
00851617007094
Brand
LOLA
Company
ALYK, INC.
Model
Ultra Thin Lubricated condoms
Published
2019-06-17
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
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
00851617007094PrimaryGS10
00851617007766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851617007094008516170070948516170070940851617007094
00851617007766008516170077668516170077660851617007766

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
079830975
Device count
12
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
00850017666733LOLAMenstrual Cup Size Mini2021-05-17
00850017666405LOLAMenstrual Cup Size 12021-01-07
00850017666412LOLAMenstrual Cup Size 22021-01-07
00850017666269LOLAPersonal Lubricant2021-01-25
00850017666016LOLA24ct Ultra Thin Lubricated Condoms2020-06-30
00850017666788LOLAPregnancy Test2021-11-24
00850017666832LOLAWashable Period Underwear Size Extra Small2022-07-08
00850017666870LOLAWashable Period Underwear Size Extra Large2022-07-08
00850017666887LOLAWashable Period Underwear Size Extra Extra Large2022-07-08
00850017666849LOLAWashable Period Underwear Size Small2022-07-07
00850017666856LOLAWashable Period Underwear Size Medium2022-07-07
00850017666863LOLAWashable Period Underwear Size Large2022-07-07
00850017666771LOLAOvulation Test2021-11-24
00850017666726LOLAThe Girl-On-The-Go Period Kit2021-04-21
00851617007223LOLA8 count light compact applicator organic cotton ta2020-02-20
00851617007230LOLA8 count regular compact applicator organic cotton 2020-02-20
00851617007247LOLA8 count super compact applicator organic cotton ta2020-02-20
00851617007254LOLA8 count super+ compact applicator organic cotton t2020-02-20
00851617007131LOLATrial Set2019-12-05
00851617007018LOLA100% organic cotton compact plastic applicator2019-06-17

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