Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TROJAN POLYURETHANE CONDOM (MODIFICATION)

K-Number: K955672 · 1996-08-29

ApplicantCarter Products
Decision Date1996-08-29
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN POLYURETHANE CONDOM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Carter Products. It received FDA 510(k) clearance on 1996-08-29 under 510(k) number K955672. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROJAN POLYURETHANE CONDOM (MODIFICATION)?

TROJAN POLYURETHANE CONDOM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-08-29. The listed applicant is Carter Products. The 510(k) number is K955672.

When did TROJAN POLYURETHANE CONDOM (MODIFICATION) receive FDA 510(k) clearance?

TROJAN POLYURETHANE CONDOM (MODIFICATION) received FDA 510(k) clearance on 1996-08-29, under 510(k) number K955672.

Who is the listed applicant for TROJAN POLYURETHANE CONDOM (MODIFICATION)?

The FDA 510(k) record lists Carter Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROJAN POLYURETHANE CONDOM (MODIFICATION)?

The FDA product code for TROJAN POLYURETHANE CONDOM (MODIFICATION) is MOL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Carter Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942697TROJAN POLYURETHANE CONDOMK912901TROJAN (TM-TBD) CONDOMK904782ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TESTK904273MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.K901202TROJAN NATURALAMB LUBRICATED NATURAL MODIFIEDK901195TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED

View all 20 devices →

Related Devices (Code: MOL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑