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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K213981
Device Name Nitrile Examination Gloves
Applicant
Emerald Glove Manufacturing Sdn Bhd
Lot 18912 & Lot 18911, Jalan Perusahaan 8,
Kawasan Perindustrian Kamunting
Taiping,  MY 834600
Applicant Contact Amran A. Aziz
Correspondent
Novo Quality Services Sdn Bhd
Unit No 625 & 627, Block A, Kelana Centre Pt. 3
Jalan Ss7/19, Kelana Jaya
Petaling Jaya,  MY 47301
Correspondent Contact Lim Pooi Yee
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/20/2021
Decision Date 11/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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