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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 K233740
Device Name Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Applicant
W.A. Rubbermate Co., Ltd.
4 Ramkhamhaeng 19 (Chareonploy)
Huamark
Bangkok,  TH 10240
Applicant Contact Prachai Kongwaree
Correspondent
W.A. Rubbermate Co., Ltd.
4 Ramkhamhaeng 19 (Chareonploy)
Huamark
Bangkok,  TH 10240
Correspondent Contact Prachai Kongwaree
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/22/2023
Decision Date 02/13/2024
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
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