FDA.reportPublic FDA data

ZIOXX Natural Rubber Latex Male Condom

Primary DI
06977708230036
Brand
ZIOXX Natural Rubber Latex Male Condom
Company
Shaoguan Regenex Pharmaceutical Co., Ltd.
Model
55mm Non-Reservoir tip
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K250034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250034000Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.2025-07-11HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977708230036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977708230036069777082300366977708230036

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
710872591
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977708239640Zl0XX(003) Natural Rubber Latex Male Condom52mm Reservoir tip2026-04-17
06977708230012ZIOXX Natural Rubber Latex Male Condom52mm Non-Reservoir tip2025-11-24
06977708230029ZIOXX Natural Rubber Latex Male Condom52mm Reservoir tip2025-11-24
06977708230043ZIOXX Natural Rubber Latex Male Condom55mm Reservoir tip2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06925634004276RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
06925634004283RogitarSuzhou Colourway New Material Co., Ltd.HIS2026-06-10
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