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)

STANDARD LATEX CONDOM

K-Number: K884399 · 1989-03-01

ApplicantSchmid Laboratories, Inc.
Decision Date1989-03-01
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STANDARD LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Schmid Laboratories, Inc.. It received FDA 510(k) clearance on 1989-03-01 under 510(k) number K884399. 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 STANDARD LATEX CONDOM?

STANDARD LATEX CONDOM is a medical device that received FDA 510(k) clearance on 1989-03-01. The listed applicant is Schmid Laboratories, Inc.. The 510(k) number is K884399.

When did STANDARD LATEX CONDOM receive FDA 510(k) clearance?

STANDARD LATEX CONDOM received FDA 510(k) clearance on 1989-03-01, under 510(k) number K884399.

Who is the listed applicant for STANDARD LATEX CONDOM?

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

What is the FDA product code for STANDARD LATEX CONDOM?

The FDA product code for STANDARD LATEX 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 Schmid Laboratories, 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.

K897140THIN CONDOM RAMSES & SHEIKK900679MINT SCENTED CONDOMSK882893CONDOMS (RAMSES, SHEIK AND KOROMEX)K880820OKAMOTO CONDOMS SPERMICIDALLY LUBRICATEDK874791CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)K880202OKAMOTO CONDOMS

View all 10 devices →

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.

↑