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)

EXTRA PROTECTION POLYURETHANE CONDOM

K-Number: K922688 · 1995-05-04

ApplicantApex Medical Technologies, Inc.
Decision Date1995-05-04
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTRA PROTECTION POLYURETHANE CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Technologies, Inc.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K922688. 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 EXTRA PROTECTION POLYURETHANE CONDOM?

EXTRA PROTECTION POLYURETHANE CONDOM is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Apex Medical Technologies, Inc.. The 510(k) number is K922688.

When did EXTRA PROTECTION POLYURETHANE CONDOM receive FDA 510(k) clearance?

EXTRA PROTECTION POLYURETHANE CONDOM received FDA 510(k) clearance on 1995-05-04, under 510(k) number K922688.

Who is the listed applicant for EXTRA PROTECTION POLYURETHANE CONDOM?

The FDA 510(k) record lists Apex Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRA PROTECTION POLYURETHANE CONDOM?

The FDA product code for EXTRA PROTECTION POLYURETHANE CONDOM 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 Apex Medical Technologies, Inc. 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.

K112165RHEA CUPK060933SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEMK954791SEMINAL FLUID COLLECTION KIT IIK930313APEX SPECIMEN BAGK902936POLYURETHANE CONDOMK871358SENSATIONS BRAND CONDOMS

View all 8 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.

↑