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FDA 510(k)

THE DOUBLE GLOVE

K-Number: K060030 · 2006-06-27

ApplicantBiobarrier, Inc.
Decision Date2006-06-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE DOUBLE GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Biobarrier, Inc.. It received FDA 510(k) clearance on 2006-06-27 under 510(k) number K060030. 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 THE DOUBLE GLOVE?

THE DOUBLE GLOVE is a medical device that received FDA 510(k) clearance on 2006-06-27. The listed applicant is Biobarrier, Inc.. The 510(k) number is K060030.

When did THE DOUBLE GLOVE receive FDA 510(k) clearance?

THE DOUBLE GLOVE received FDA 510(k) clearance on 2006-06-27, under 510(k) number K060030.

Who is the listed applicant for THE DOUBLE GLOVE?

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

What is the FDA product code for THE DOUBLE GLOVE?

The FDA product code for THE DOUBLE 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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