Decision Date2009-01-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Siam Sempermed Corp., Ltd.. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K081911. 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 NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE?
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K081911.
When did NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE receive FDA 510(k) clearance?
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE received FDA 510(k) clearance on 2009-01-15, under 510(k) number K081911.
Who is the listed applicant for NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE?
The FDA 510(k) record lists Siam Sempermed Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE?
The FDA product code for NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE is LZA.
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Other records listing Siam Sempermed Corp., Ltd. as applicant
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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.