FEIYUE

Vinyl Patient Examination Glove

FEIYUE GLOVE CO., LTD.

The following data is part of a premarket notification filed by Feiyue Glove Co., Ltd. with the FDA for Feiyue.

Pre-market Notification Details

• Device ID: K140242
• 510k Number: K140242
• Device Name: FEIYUE
• Classification: Vinyl Patient Examination Glove
• Applicant: FEIYUE GLOVE CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD Haidian Dis, Beijing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; FEIYUE GLOVE CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD Haidian Dis, Beijing, CN 100083
• Product Code: LYZ
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-30
• Decision Date: 2014-06-12
• Summary: summary