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FDA 510(k)

SURE

K-Number: K982380 · 1999-02-26

ApplicantPleasure Latex Products Sdn. Bhd.
Decision Date1999-02-26
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURE is the device name listed in this FDA 510(k) record. The listed applicant is Pleasure Latex Products Sdn. Bhd.. It received FDA 510(k) clearance on 1999-02-26 under 510(k) number K982380. 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 SURE?

SURE is a medical device that received FDA 510(k) clearance on 1999-02-26. The listed applicant is Pleasure Latex Products Sdn. Bhd.. The 510(k) number is K982380.

When did SURE receive FDA 510(k) clearance?

SURE received FDA 510(k) clearance on 1999-02-26, under 510(k) number K982380.

Who is the listed applicant for SURE?

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

What is the FDA product code for SURE?

The FDA product code for SURE is HIS.

Related PubMed Literature

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.

PMID: 42375709Multimodal LLM vs. Human-Measured Features for AI Predictions of Autism in Home Videos.Algorithms ()PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology ()PMID: 39556835Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.Annals of internal medicine ()PMID: 39232944Evaluating Medical Devices in Nephrology Using Patient-Reported Outcome and Experience Measures.Seminars in nephrology ()

Other records listing Pleasure Latex Products Sdn. Bhd. 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.

K022156LATEX ULTRASONIC PROBE COVERK023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOURK021875MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOMK020272MALE LATEX CONDOM WITH RIBBED SURFACEK002571MULITPLE MALE LATX CONDOMK001377SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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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.

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