FDA.reportPublic FDA data

MAXX Large Flare

Primary DI
00016169030130
Brand
MAXX Large Flare
Company
MAYER LABORATORIES, INC.
Model
Kimono MAXX
Catalog number
03013
Device description
Latex Condoms 1000 ct
Published
2025-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K946376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946376000MAXXMayer Laboratories1995-09-22HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00016169030130PrimaryGS10
90016169030133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016169030130000161690301300161690301300016169030130
9001616903013390016169030133

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
175425982
Device count
1000
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
00016169010248ThinKimono10242025-10-06
00016169050404MicroThinKimono50402025-10-06
00016169070242MicroThin Ribbed + Sensi-DotsKimono70242025-10-06
00016169088032Kimono MicroThin XLKimono Microthin XL Condoms088032025-10-06
00016169114090Callvin RegularCallvin Latex Condom114092025-10-06
00016169114106Callvin GoldCallvin Latex Condom114102025-10-06
00016169114113PlaygroundPlayground Condoms114112025-10-06
00016169700057Nauox Yin YangNauox Yin Yang700052025-10-06
00016169700064Nauox Holy HoneyNauox Holy Honey700062025-10-06
00016169700071Nauox Dulce DreamsNauox Dulce Dreams700072025-10-06
00016169700088Nauox Sweet HavenNauox Sweet Haven700082025-10-06
00016169700095Naoux Agave NectarNaoux Agave Nectar700092025-10-06
00016169700194Femme GlydeFemme Glide Natural Lubriant700192025-10-06
00198715811087Kindra V LubeKindra Silicone Lubricant700182025-10-06
06279870714292NixitNixit Natural Lubricant700042023-11-03
00860004693543Pill ClubPeriod Care Reg Pads999-001-042022-02-09
00860004693550Pill ClubPeriod Care Super Pads999-001-052022-02-09
00860004693567Pill ClubPeriod Care Combo Pads999-001-062022-02-09
00860004693598Pill ClubPeriod Care Combo Tampons&Pads999-001-092022-02-09
00060004114042Pill ClubLatex Condoms114032022-02-09

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