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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
Predetermined Change
Control Plan Authorized		 No
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