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FDA 510(k)

REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE

K-Number: K020308 · 2002-04-03

ApplicantSsl America'S, Inc.
Decision Date2002-04-03
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Ssl America'S, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020308. 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 SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE?

REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Ssl America'S, Inc.. The 510(k) number is K020308.

When did REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE receive FDA 510(k) clearance?

REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020308.

Who is the listed applicant for REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE?

The FDA 510(k) record lists Ssl America'S, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE?

The FDA product code for REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S 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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