POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)

Vinyl Patient Examination Glove

SHANDONG HONGXIN CHEMICALS CO., LTD

The following data is part of a premarket notification filed by Shandong Hongxin Chemicals Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves, Clear(non-colored).

Pre-market Notification Details

• Device ID: K122828
• 510k Number: K122828
• Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
• Classification: Vinyl Patient Examination Glove
• Applicant: SHANDONG HONGXIN CHEMICALS CO., LTD RM. 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; SHANDONG HONGXIN CHEMICALS CO., LTD RM. 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO 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: 2012-09-17
• Decision Date: 2012-12-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06973073130247	K122828	000
06973073130230	K122828	000
06973073130209	K122828	000
06973073130148	K122828	000