FDA.reportPublic FDA data

Sustain Natural

Primary DI
00856078005382
Brand
Sustain Natural
Company
GROVE COLLABORATIVE, INC.
Model
Sustain XL condoms w/ ribs & dots (10 pack)
Catalog number
10XL04
Device description
Lubricated Natural Latex Condom XL w/ ribs & dots
Published
2018-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K131866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131866000SUSTAINHollender Sustainable Brands, LLC2014-05-01HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856078005389PackageGS16In Commercial Distribution
20856078005386PackageGS18In Commercial Distribution
00856078005382PrimaryGS10
00856078005870Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085607800538910856078005389
2085607800538620856078005386
00856078005382008560780053828560780053820856078005382
00856078005870008560780058708560780058700856078005870

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

Contacts#

Phone, Email table
PhoneEmail
8028462849questions@sustainnatural.com

Regulatory Flags#

DUNS number
022200656
Device count
10
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
00850008019005Sustain160TMPR2020-05-04
00850008019012Sustain160TMPS2020-05-04
00856078005511Sustain NaturalApplicator, Regular Tampon2017-05-09
00856078005528Sustain NaturalApplicator, Super Tampon2017-05-09
00856078005535Sustain NaturalApplicator, Half Reg. & Half Super Tampon2017-05-09
00856078005542Sustain NaturalApplicator, Mostly Regular Tampon2017-05-09
00856078005559Sustain NaturalApplicator, Mostly Super Tampon2017-05-09
00856078005177SustainSustain Lavender Personal Lubricant 2.5 oz.100LAV212017-10-09
00856078005184SustainSustain Unscented Personal Lubricant 2.5 oz100UNSCNT222017-10-09
10856078005075SustainSustain Comfort fit Condoms (144 pack)80CF022017-07-24
10856078005082SustainSustain Ultra thin condoms (144 pack)80UT032017-07-24
10856078005365Sustain NaturalSustain XL w/ ribs & dots condoms (144 pack)80XL042018-06-06
00856078005023SustainSustain Comfort fit Condoms (3 pack)30CF022017-04-06
00856078005030SustainSustain Comfort fit Condoms (10 pack)10CF022017-04-06
00856078005054SustainSustain Ultra thin condoms (10 pack)10UT032017-04-07
00856078005399SustainSustain Ultra thin Condoms (24 pack)24UT032017-04-06
00856078005016SustainSustain Natural Tailored fit condoms (10 pack)10TF012018-03-24
00856078005047Sustain Sustain Ultra thin Condoms (3 pack)03UT032017-04-06

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