FDA.reportPublic FDA data

WINK CLOSER

Primary DI
80028373149993
Brand
WINK CLOSER
Company
OKAMOTO USA, INC.
Model
14999
Device description
WINK Closer Condom (1008 pc case)
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2435840000.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.2025-02-18HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00028373149997PrimaryGS10
80028373149993Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00028373149997000283731499970283731499970028373149997
8002837314999380028373149993

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

Regulatory Flags#

DUNS number
175752724
Device count
1008
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00028373140116WINK CLOSER140112026-03-11
80028373140105WINK CLOSER140112026-03-11
00028373149997WINK CLOSER149992026-03-06
00028373749104Beyond BodiHeat®749102020-08-26
00028373749821Beyond BodiHeat®749822020-08-26
00028373749838Beyond BodiHeat®749832020-08-26
00028373749845Beyond BodiHeat®749842020-08-26
00028373749883Beyond BodiHeat®749882020-08-26
00028373149980WINK CLOSER149982024-09-06
80028373149986WINK CLOSER149982024-09-06
00028373040034004® ZERO ZERO FOUR® Condoms04003040032016-09-22
00028373040102004® ZERO ZERO FOUR® Condoms04010040102016-09-22
00028373040249004® ZERO ZERO FOUR® Condoms04024040242016-09-22
00028373050033004® ZERO ZERO FOUR® Aloe Condoms05003050032016-09-22
00028373050101004® ZERO ZERO FOUR® Aloe Condoms05010050102016-09-22
00028373050248004® ZERO ZERO FOUR® Aloe Condoms05024050242016-09-22
00028373410127BEYOND SEVEN ® ALOE ENRICHED Condoms41012410122016-09-22
00028373040010004® ZERO ZERO FOUR® Condoms04001040012016-09-22
10028373040031004® ZERO ZERO FOUR® Condoms04003040032016-09-22
10028373040109004® ZERO ZERO FOUR® Condoms04010040102016-09-22

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00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
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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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