Decision Date2012-09-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, 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 2012-09-10 under 510(k) number K122363. 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, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K122363.
When did NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE receive FDA 510(k) clearance?
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE received FDA 510(k) clearance on 2012-09-10, under 510(k) number K122363.
Who is the listed applicant for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, 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, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?
The FDA product code for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is LZA.
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Other records listing Siam Sempermed Corp., Ltd. as applicant
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.