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)

HTL MALE CONDOM

K-Number: K980019 · 1998-04-01

ApplicantReddy Medtech Health Products , Ltd.
Decision Date1998-04-01
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HTL MALE CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Reddy Medtech Health Products , Ltd.. It received FDA 510(k) clearance on 1998-04-01 under 510(k) number K980019. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HTL MALE CONDOM?

HTL MALE CONDOM is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Reddy Medtech Health Products , Ltd.. The 510(k) number is K980019.

When did HTL MALE CONDOM receive FDA 510(k) clearance?

HTL MALE CONDOM received FDA 510(k) clearance on 1998-04-01, under 510(k) number K980019.

Who is the listed applicant for HTL MALE CONDOM?

The FDA 510(k) record lists Reddy Medtech Health Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HTL MALE CONDOM?

The FDA product code for HTL MALE CONDOM is HIS.

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 Reddy Medtech Health Products , Ltd. 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.

K974323LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANTK974326LATEX CONDOMS (NATURAL COLOUR)K974324LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT

Related Devices (Code: HIS)

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

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.

↑