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FDA 510(k)

REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE

K-Number: K970924 · 1997-04-01

ApplicantRegent Medical
Decision Date1997-04-01
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Regent Medical. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K970924. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE?

REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Regent Medical. The 510(k) number is K970924.

When did REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE receive FDA 510(k) clearance?

REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE received FDA 510(k) clearance on 1997-04-01, under 510(k) number K970924.

Who is the listed applicant for REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE?

The FDA 510(k) record lists Regent Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE?

The FDA product code for REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE is KGO.

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Related Devices (Code: KGO)

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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