FDA.reportPublic FDA data

CautionWear Black Ice

Primary DI
00850836007373
Brand
CautionWear Black Ice
Company
CAUTION WEAR CORP
Model
CW0001BI
Device description
Male Latex Condom, Parallel-Sided, Smooth Surface, Ultra Thin, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Published
2017-02-21
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
K012665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012665000ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANTInnolatex Sdn. Bhd2001-11-09HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850836007366PackageGS11000In Commercial Distribution
00850836007373PackageGS14In Commercial Distribution
00850836007380PackageGS14000In Commercial Distribution
00850836007359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850836007366008508360073668508360073660850836007366
00850836007373008508360073738508360073730850836007373
00850836007380008508360073808508360073800850836007380
00850836007359008508360073598508360073590850836007359

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
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
00850836007410CautionWear PPECW0001PPE2017-02-20
00850836007502CautionWear GrandeCW0001GR2017-10-11
00850836007434CautionWear Mission-707CW0001M7072017-02-23
00850836007458CautionWear Mission-707CW0001M7072017-02-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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