FDA.reportPublic FDA data

CautionWear Grande

Primary DI
00850836007502
Brand
CautionWear Grande
Company
CAUTION WEAR CORP
Model
CW0001GR
Device description
Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Published
2017-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
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
K012964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K01296400056MM CONDOM,MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2001-11-09HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850836007489PackageGS11000In Commercial Distribution
00850836007496PackageGS14In Commercial Distribution
00850836007502PackageGS14000In Commercial Distribution
00850836007847PackageGS124In Commercial Distribution
00850836007854PackageGS150In Commercial Distribution
00850836007861PackageGS1100In Commercial Distribution
00850836007878PackageGS1200In Commercial Distribution
00850836007472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850836007489008508360074898508360074890850836007489
00850836007496008508360074968508360074960850836007496
00850836007502008508360075028508360075020850836007502
00850836007847008508360078478508360078470850836007847
00850836007854008508360078548508360078540850836007854
00850836007861008508360078618508360078610850836007861
00850836007878008508360078788508360078780850836007878
00850836007472008508360074728508360074720850836007472

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
Storage Environment Temperature32 Degrees Celsius100 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
603-598-8500anatoli@cautionwearcorp.com

Regulatory Flags#

DUNS number
177056145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850836007472CautionWear GrandeCW0001GR2017-10-11
00850836007113CautionWear L.A.Confidential - Dark DesireLAC0001DD2021-06-21
00850836007168CautionWear L.A.Confidential - Silky TouchLAC0001ST2021-06-21
00850836007762CautionWear L.A.Confidential - Dark DesireLAC0001DD2021-06-21
00850836007724CautionWear L.A.Confidential - Silky TouchLAC0001ST2021-06-21
00850836007069CautionWear L.A.Confidential - Secret PassionLAC0001SP2021-06-18
00850836007397CautionWear PPECW0001PPE2017-02-20
00850836007014L.A.Confidential - Love TriangleLAC0001LT2017-10-11
00850836007212CautionWear Iron GripCW0001IG2016-09-03
00850836007298CautionWear Wild RoseCW0001WR2016-10-10
00850836007335FPACU0001FPA2016-10-10
00850836007359CautionWear Black IceCW0001BI2017-02-21
00850836007250CautionWear ClassicCW0001CL2016-09-02
00850836007328CautionWear Wild RoseCW0001WR2016-10-10
00850836007342FPACU0001FPA2016-10-10
00850836007373CautionWear Black IceCW0001BI2017-02-21
00850836007410CautionWear PPECW0001PPE2017-02-20
00850836007434CautionWear Mission-707CW0001M7072017-02-23
00850836007458CautionWear Mission-707CW0001M7072017-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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06925634004269RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004290RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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