Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Surgeon'S Gloves
510(k) Number K231446
Device Name Single-Use Latex Sterile Surgical Gloves (SG100)
Applicant
Fitone Latex Products Co., Ltd. Guangdong
No.5 Huitong road, Lingbei Industrial Zone, Suixi
Zhanjiang,  CN 524338
Applicant Contact Christine Ou
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd
Room 1308, Baohua International Plaza, West Guangzhong Road
555, Jingan District
Shanghai,  CN 200072
Correspondent Contact Kyra Kang
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/18/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-