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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 K210369
Device Name Powder Free Nitrile Examination Glove
Applicant
Pastel Glove Sdn Bhd
Pt285724, Jalan Pusing, Taman Perindustrian Perabot Negeri
Park
Pusing,  MY 31550
Applicant Contact Siou Wei Law
Correspondent
Pastel Glove Sdn Bhd
Pt285724, Jalan Pusing, Taman Perindustrian Perabot Negeri
Park
Pusing,  MY 31550
Correspondent Contact Terence Lim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/08/2021
Decision Date 05/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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