FDA.reportPublic FDA data

Sustain

Primary DI
10856078005075
Brand
Sustain
Company
GROVE COLLABORATIVE, INC.
Model
Sustain Comfort fit Condoms (144 pack)
Catalog number
80CF02
Device description
Lubricated Natural Latex Condom
Published
2017-07-24
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
20856078005072PackageGS18In Commercial Distribution
10856078005075PrimaryGS10
00856078005627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085607800507220856078005072
1085607800507510856078005075
00856078005627008560780056278560780056270856078005627

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
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
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
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
08906007135399SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135436SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31