FDA.reportPublic FDA data

Glyde

Primary DI
19556807570843
Brand
Glyde
Company
RICHTER RUBBER TECHNOLOGY SDN. BHD.
Model
Pro Maxi
Catalog number
QA-224
Device description
Natural latex male condom. Transparent, plain, nominal width 57 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested
Published
2025-12-02
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
19556807570843PrimaryGS10
09556807500850Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955680757084319556807570843
09556807500850095568075008509556807500850

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.

Regulatory Flags#

DUNS number
652647942
Device count
100
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
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
09556807403304XO!Ultra Thin 3'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
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
08906007135474SKORE Thin Condoms with FlavorsTTK HEALTHCARE LIMITEDHIS2025-01-31