YONGFA

Vinyl Patient Examination Glove

YONGFA GLOVE CO., LTD.

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

Pre-market Notification Details

• Device ID: K140246
• 510k Number: K140246
• Device Name: YONGFA
• Classification: Vinyl Patient Examination Glove
• Applicant: YONGFA 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; YONGFA 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: 2014-11-06
• Summary: summary