FDA.reportPublic FDA data

Sustain

Primary DI
00856078005030
Brand
Sustain
Company
GROVE COLLABORATIVE, INC.
Model
Sustain Comfort fit Condoms (10 pack)
Catalog number
10CF02
Device description
Lubricated Natural Latex Condom
Published
2017-04-06
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
10856078005037PackageGS16In Commercial Distribution
20856078005034PackageGS18In Commercial Distribution
00856078005030PrimaryGS10
00856078005627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085607800503710856078005037
2085607800503420856078005034
00856078005030008560780050308560780050300856078005030
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
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
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

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Primary DI, Brand, Company table
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00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
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08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20