FDA.reportPublic FDA data

Durex Air Large Condom

Primary DI
40302340876498
Brand
Durex Air Large Condom
Company
RB Health (us) LLC
Model
Condom
Device description
Condom
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200672000Durex Penck Standard, Durex Penck XLRb Health (Us), LLC2020-11-06HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302340876497PackageGS16In Commercial Distribution
20302340876494PackageGS18In Commercial Distribution
00302340876490PrimaryGS10
40302340876498Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030234087649710302340876497
2030234087649420302340876494
00302340876490003023408764903023408764900302340876490
4030234087649840302340876498

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)756-5488xxx@xxx.xxx

Regulatory Flags#

DUNS number
081049410
Device count
3
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
50302340996131Durex Intense003023409961362026-03-02
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
10067981993971KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
10067981993988KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087253KY Intense CondomsCondom2019-05-30
00067981087260KY Intense CondomsCondom2019-05-30
00067981087277KY Intense CondomsCondom2019-10-14
00067981087758KY Extra Lubricated CondomsCondom2019-06-12
00067981087765KY Intense CondomsCondom2019-06-12
00067981941845KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981962161KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981087925KY UltraGel Personal Lubricant000679810873522016-09-20
00067981087932KY UltraGel Personal Lubricant000679810873762016-09-20
00067981963038KY Natural Feeling with Botanical Essence Lubricant & Massage GelPersonal Lubricant2018-10-31
00067981087178KY Extra Lubricated CondomsCondom2018-10-31

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