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FDA 510(k)

GUARDIAN & JANITEX CONDOM/PROPHYLACTIC

K-Number: K896098 · 1990-12-19

ApplicantAllied Rubber Industries Sdn. Bhd.
Decision Date1990-12-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GUARDIAN & JANITEX CONDOM/PROPHYLACTIC is the device name listed in this FDA 510(k) record. The listed applicant is Allied Rubber Industries Sdn. Bhd.. It received FDA 510(k) clearance on 1990-12-19 under 510(k) number K896098. 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 GUARDIAN & JANITEX CONDOM/PROPHYLACTIC?

GUARDIAN & JANITEX CONDOM/PROPHYLACTIC is a medical device that received FDA 510(k) clearance on 1990-12-19. The listed applicant is Allied Rubber Industries Sdn. Bhd.. The 510(k) number is K896098.

When did GUARDIAN & JANITEX CONDOM/PROPHYLACTIC receive FDA 510(k) clearance?

GUARDIAN & JANITEX CONDOM/PROPHYLACTIC received FDA 510(k) clearance on 1990-12-19, under 510(k) number K896098.

Who is the listed applicant for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC?

The FDA 510(k) record lists Allied Rubber Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC?

The FDA product code for GUARDIAN & JANITEX CONDOM/PROPHYLACTIC 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 Allied Rubber Industries 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.

K892487PATIENT EXAMINATION GLOVES

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.

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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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