FDA.reportPublic FDA data

Primeros

Primary DI
19556807304134
Brand
Primeros
Company
RICHTER RUBBER TECHNOLOGY SDN. BHD.
Model
Trans Pride Hookup 9 x 3's
Catalog number
QA-224
Device description
Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested.”
Published
2024-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K070511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070511000RICHTER MALE LATEX CONDOMRichter Rubber Technology Sbn Bhd2008-01-14HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19556807304134PrimaryGS10
09556807304144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955680730413419556807304134
09556807304144095568073041449556807304144

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
Special Storage Condition, Specify00Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Regulatory Flags#

DUNS number
652647942
Device count
3
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
29556807531926XO!Hi-Sensation 3'sQA-2242025-12-15
09556807501949XO!Hi-Sensation 3'sQA-2242025-12-15
19556807570843GlydePro MaxiQA-2242025-12-02
19556807570867GlydePro Slim FitQA-2242025-12-02
19556807570881GlydePro UltraQA-2242025-12-02
09556807500850GlydePro MaxiQA-2242025-12-02
09556807500874GlydePro Slim FitQA-2242025-12-02
09556807500898GlydePro UltraQA-2242025-12-02
29556807352224XO!Ultra thin 6'sQA-2242025-02-27
29556807352255XO!Hi-Sensation 6'sQA-2242025-02-27
29556807382283XO!Ultra Thin 12'sQA-2242025-02-27
29556807382313XO!Hi-Sensation 12'sQA-2242025-02-27
29556807433282XO!Ultra Thin 3'sQA-2242025-02-27
29556807481504InspireStandard 12'sQA-2242025-02-27
29556807481535InspireUltra Thin 12'sQA-2242025-02-27
29556807492470XO!Ultra Thin 24'sQA-2242025-02-27
09556807322247XO!Ultra thin 6'sQA-2242025-02-27
09556807322278XO!Hi-Sensation 6'sQA-2242025-02-27
09556807342306XO!Ultra Thin 12'sQA-2242025-02-27
09556807342337XO!Hi-Sensation 12'sQA-2242025-02-27

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