Decision Date2008-08-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SKINSENSE POLYISOPRENE UNDERGLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2008-08-26 under 510(k) number K081180. 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 SKINSENSE POLYISOPRENE UNDERGLOVE?
SKINSENSE POLYISOPRENE UNDERGLOVE is a medical device that received FDA 510(k) clearance on 2008-08-26. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K081180.
When did SKINSENSE POLYISOPRENE UNDERGLOVE receive FDA 510(k) clearance?
SKINSENSE POLYISOPRENE UNDERGLOVE received FDA 510(k) clearance on 2008-08-26, under 510(k) number K081180.
Who is the listed applicant for SKINSENSE POLYISOPRENE UNDERGLOVE?
The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SKINSENSE POLYISOPRENE UNDERGLOVE?
The FDA product code for SKINSENSE POLYISOPRENE UNDERGLOVE is KGO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.