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FDA 510(k)

ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

K-Number: K981621 · 1998-06-19

ApplicantSuretex Prophylactics (India) , Ltd.
Decision Date1998-06-19
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS 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 1998-06-19 under 510(k) number K981621. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS?

ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS is a medical device that received FDA 510(k) clearance on 1998-06-19. The listed applicant is Suretex Prophylactics (India) , Ltd.. The 510(k) number is K981621.

When did ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS receive FDA 510(k) clearance?

ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS received FDA 510(k) clearance on 1998-06-19, under 510(k) number K981621.

Who is the listed applicant for ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS?

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 ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS?

The FDA product code for ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS is LTZ.

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 Suretex Prophylactics (India) , 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.

K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABELK983320ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS

Related Devices (Code: LTZ)

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.

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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