BYTECH

Vinyl Patient Examination Glove

BYTECH DONGTAI CO., LTD.

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

Pre-market Notification Details

• Device ID: K130101
• 510k Number: K130101
• Device Name: BYTECH
• Classification: Vinyl Patient Examination Glove
• Applicant: BYTECH DONGTAI CO., LTD. RM 1606 BUILDING 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD. HAI DI Beijing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; BYTECH DONGTAI CO., LTD. RM 1606 BUILDING 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD. HAI DI 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: 2013-01-15
• Decision Date: 2013-11-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10853927007181	K130101	000
10853927007174	K130101	000
10853927007167	K130101	000
10853927007150	K130101	000
10853927007099	K130101	000
10853927007082	K130101	000
10853927007075	K130101	000
10853927007068	K130101	000