Decision Date2022-06-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TC Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Thanh Cong Pharmaceutical and Trading Company Limited. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K221186. 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 TC Gloves?
TC Gloves is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Thanh Cong Pharmaceutical and Trading Company Limited. The 510(k) number is K221186.
When did TC Gloves receive FDA 510(k) clearance?
TC Gloves received FDA 510(k) clearance on 2022-06-16, under 510(k) number K221186.
Who is the listed applicant for TC Gloves?
The FDA 510(k) record lists Thanh Cong Pharmaceutical and Trading Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TC Gloves?
The FDA product code for TC Gloves is LZA.
Related Clinical Trials
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Other records listing Thanh Cong Pharmaceutical and Trading Company Limited 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.
Related Devices (Code: LZA)
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.