Decision Date2012-05-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
C2 MEDICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Amercare, Inc.. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K113639. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C2 MEDICAL GLOVES?
C2 MEDICAL GLOVES is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Amercare, Inc.. The 510(k) number is K113639.
When did C2 MEDICAL GLOVES receive FDA 510(k) clearance?
C2 MEDICAL GLOVES received FDA 510(k) clearance on 2012-05-08, under 510(k) number K113639.
Who is the listed applicant for C2 MEDICAL GLOVES?
The FDA 510(k) record lists Amercare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C2 MEDICAL GLOVES?
The FDA product code for C2 MEDICAL GLOVES is LZA.
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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.