510(k) K021388

Device
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
Applicant
Seal Polymer Industries Bhd.
510(k) number
K021388
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-10
Date received
2002-05-02
Regulation
880.6250
Classification name
Latex Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
CHUN CHOOI FONG
Address
Lot 72706,Jalan Lahat,Kawasan Perindustrian Bukit Merah Lahat, Perak MY 31500 31500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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