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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K262427
Device Name Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
Applicant
Hh Global Technology, Inc.
6303 Woodlake Dr.
Buford,  GA  30518
Applicant Contact Grace Hammond
Correspondent
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, # 278, Hangkong Rd., Tianjin Pilot Free Trade
Tianjin,  CN 300308
Correspondent Contact Ningning Wang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/16/2026
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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