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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K954081
Device Name PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE)
Applicant
Tan Chong Rubber Gloves Sdn Bhd
Lot 3 Jalan Perusahaan Satu
Kawasan Perindustrian Batu
Caves, Batu Caves, Selangor,  MY 68100
Applicant Contact GAN BOON CHENG
Correspondent
Tan Chong Rubber Gloves Sdn Bhd
Lot 3 Jalan Perusahaan Satu
Kawasan Perindustrian Batu
Caves, Batu Caves, Selangor,  MY 68100
Correspondent Contact GAN BOON CHENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/31/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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