FDA 510(k) Application Details - K211810

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211810
Device Name	Polymer Patient Examination Glove
Applicant	PT. Shamrock Manufacturing Corpora JL. Raya Medan - Namorambe Ps IV Kab. Deli Serdang 20356 ID Other 510(k) Applications for this Company
Contact	Jeni Chuason Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2021
Decision Date	05/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review