FDA 510(k) Application Details - K240051

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K240051
Device Name Polymer Patient Examination Glove
Applicant Lingshi Hongruida Health Protection Technology Co., Ltd.
Yangjiayuan, Liangdu Town, Lingshi County
Jinzhong 031300 CN
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Contact Tinglong Chai
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 01/08/2024
Decision Date 02/29/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240051


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