FDA.reportPublic FDA data

Sustain Natural

Primary DI
10856078005365
Brand
Sustain Natural
Company
GROVE COLLABORATIVE, INC.
Model
Sustain XL w/ ribs & dots condoms (144 pack)
Catalog number
80XL04
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
20856078005362PackageGS18In Commercial Distribution
10856078005365PrimaryGS10
00856078005870Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085607800536220856078005362
1085607800536510856078005365
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.

Contacts#

Phone, Email table
PhoneEmail
8028462849questions@sustainnatural.com

Regulatory Flags#

DUNS number
022200656
Device count
144
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
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
00856078005382Sustain NaturalSustain XL condoms w/ ribs & dots (10 pack)10XL042018-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08859798106553LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106560LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08906007135351SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31