Decision Date2022-05-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PP Care Nitrile Examination Gloves is a medical device manufactured by Eg Group Product and Services Co., Ltd.. It received FDA 510(k) clearance on 2022-05-26 under approval number K212629. 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 PP Care Nitrile Examination Gloves?
PP Care Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Eg Group Product and Services Co., Ltd.. The 510(k) number is K212629.
When was PP Care Nitrile Examination Gloves approved by the FDA?
PP Care Nitrile Examination Gloves received FDA 510(k) clearance on 2022-05-26, under approval number K212629.
What company makes PP Care Nitrile Examination Gloves?
PP Care Nitrile Examination Gloves is manufactured by Eg Group Product and Services Co., Ltd..
What is the FDA product code for PP Care Nitrile Examination Gloves?
The FDA product code for PP Care Nitrile Examination Gloves is LZA.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.