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FDA 510(k)

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL

K-Number: K992081 · 1999-08-19

ApplicantSuretex Prophylactics (India) , Ltd.
Decision Date1999-08-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL is the device name listed in this FDA 510(k) record. The listed applicant is Suretex Prophylactics (India) , Ltd.. It received FDA 510(k) clearance on 1999-08-19 under 510(k) number K992081. 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 VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL?

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL is a medical device that received FDA 510(k) clearance on 1999-08-19. The listed applicant is Suretex Prophylactics (India) , Ltd.. The 510(k) number is K992081.

When did VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL receive FDA 510(k) clearance?

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL received FDA 510(k) clearance on 1999-08-19, under 510(k) number K992081.

Who is the listed applicant for VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL?

The FDA 510(k) record lists Suretex Prophylactics (India) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL?

The FDA product code for VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL is HIS.

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Other records listing Suretex Prophylactics (India) , Ltd. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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