Medical Examination Gloves (Tested for Use with Chemotherapy)
K-Number: K212506 · 2021-11-07
Decision Date2021-11-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medical Examination Gloves (Tested for Use with Chemotherapy) is a medical device manufactured by Guangdong Gymda Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-11-07 under approval number K212506. 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 Medical Examination Gloves (Tested for Use with Chemotherapy)?
Medical Examination Gloves (Tested for Use with Chemotherapy) is a medical device that received FDA 510(k) clearance on 2021-11-07. It is manufactured by Guangdong Gymda Medical Technology Co.,Ltd. The 510(k) number is K212506.
When was Medical Examination Gloves (Tested for Use with Chemotherapy) approved by the FDA?
Medical Examination Gloves (Tested for Use with Chemotherapy) received FDA 510(k) clearance on 2021-11-07, under approval number K212506.
What company makes Medical Examination Gloves (Tested for Use with Chemotherapy)?
Medical Examination Gloves (Tested for Use with Chemotherapy) is manufactured by Guangdong Gymda Medical Technology Co.,Ltd.
What is the FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy)?
The FDA product code for Medical Examination Gloves (Tested for Use with Chemotherapy) 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.