FDA.reportPublic FDA data

Royal

Primary DI
00850012584100
Brand
Royal
Company
M3 Global Enterprises, LLC
Model
Royal Strawberry Condoms Box of 10
Published
2019-10-21
Public version status
Update
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
K161195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161195000Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC2016-08-25HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012584100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012584100008500125841008500125841000850012584100

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
080373674
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
00850012584445RoyalRoyal Strawberry Condoms Box of 122024-01-01
00850012584001RoyalRoyal Natural Condoms Box of 32019-10-21
00850012584018RoyalRoyal Natural Condoms Box of 102019-10-21
00850012584117RoyalRoyal Strawberry Condoms Box of 32019-10-21
00850012584124RoyalRoyal Strawberry Condoms Box of 202019-10-21
00850012584131RoyalRoyal Chocolate Condoms Box of 102019-10-21
00850012584148RoyalRoyal Chocolate Condoms Box of 32019-10-21
00850012584155RoyalRoyal Chocolate Condoms Box of 202019-10-21
00646437668811RoyalRoyal Natural Condoms Box of 202016-10-12
00646437668828RoyalRoyal Chocolate Condoms Box of 102016-10-12
00646437668835RoyalRoyal Strawberry Condoms Box of 102016-10-12
00646437668859RoyalRoyal Black Grape Condoms Box of 102016-10-12
00646437668866RoyalRoyal Natural Condoms Box of 102016-10-12
00646437668873RoyalRoyal Chocolate Condoms Box of 32016-10-12
00646437668880RoyalRoyal Coffee Condoms Box of 32016-10-12
00646437668897RoyalRoyal Black Grape Condoms Box of 32016-10-12
00646437668903RoyalRoyal Natural Condoms Box of 32016-10-12
00646437668910RoyalRoyal Coffee Condoms Box of 202016-10-12
00646437668958RoyalRoyal Strawberry Condoms Box of 32016-10-12
00646437668989RoyalRoyal Chocolate Condoms Box of 202016-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107383LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106553LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106560LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08906007135351SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135399SKORE Dotted CondomsTTK HEALTHCARE LIMITEDHIS2025-01-31
08906007135436SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31