POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

Polymer Patient Examination Glove

SHANDONG YINGHONG MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Shandong Yinghong Medical Products Co., Ltd. with the FDA for Powder-free Nitrile Patient Examination Gloves.

Pre-market Notification Details

• Device ID: K110981
• 510k Number: K110981
• Device Name: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
• Classification: Polymer Patient Examination Glove
• Applicant: SHANDONG YINGHONG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710
• Contact: Frank Liu
• Correspondent: Frank Liu; SHANDONG YINGHONG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-07
• Decision Date: 2011-07-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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