PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K111464
Device Name PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
DIPPED PRODUCTS (THAILAND) LTD
82/2 moo 9, tumbon rattapum
amphur khun nieng
songkla, 

TH

90220

Applicant Contact l.g.s. gunawardana
Correspondent
DIPPED PRODUCTS (THAILAND) LTD
82/2 moo 9, tumbon rattapum
amphur khun nieng
songkla, 

TH

90220

Correspodent Contact l.g.s. gunawardana
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/26/2011
Decision Date 04/19/2012
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