YUSHENG

Vinyl Patient Examination Glove

ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Zibo Yusheng Plastic Products Co., Ltd. with the FDA for Yusheng.

Pre-market Notification Details

• Device ID: K141108
• 510k Number: K141108
• Device Name: YUSHENG
• Classification: Vinyl Patient Examination Glove
• Applicant: ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG. 1. JINAXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Bejing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG. 1. JINAXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Bejing, 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: 2014-04-29
• Decision Date: 2014-09-16
• Summary: summary