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FDA 510(k)

SHEER THIN AROMAS RED LATEX CONDOM

K-Number: K010028 · 2001-03-30

ApplicantEagle Twe, Inc.
Decision Date2001-03-30
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHEER THIN AROMAS RED LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Twe, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K010028. 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 SHEER THIN AROMAS RED LATEX CONDOM?

SHEER THIN AROMAS RED LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Eagle Twe, Inc.. The 510(k) number is K010028.

When did SHEER THIN AROMAS RED LATEX CONDOM receive FDA 510(k) clearance?

SHEER THIN AROMAS RED LATEX CONDOM received FDA 510(k) clearance on 2001-03-30, under 510(k) number K010028.

Who is the listed applicant for SHEER THIN AROMAS RED LATEX CONDOM?

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

What is the FDA product code for SHEER THIN AROMAS RED LATEX CONDOM?

The FDA product code for SHEER THIN AROMAS RED 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.

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Other records listing Eagle Twe, 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.

K051273DIVAS DUAL PLEASURE MALE LATEX CONDOMK004051SHEER THIN AROMAS YELLOW LATEX CONDOMK004036SHEER THIN AROMAS GREEN LATEX CONDOMK004016SHEER THIN AROMAS BLUE LATEX CONDOM

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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