Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color

Polymer Patient Examination Glove

XINGDA MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Xingda Medical Products Co., Ltd. with the FDA for Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color.

Pre-market Notification Details

• Device ID: K152720
• 510k Number: K152720
• Device Name: Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
• Classification: Polymer Patient Examination Glove
• Applicant: XINGDA MEDICAL PRODUCTS CO., LTD. SOUTH OF SHENGZHUANG VILLAGE, LUANNAN COUNTY Tangshan, CN 063502
• Contact: Zhang Lixia
• Correspondent: Chu Xiaoan; XINGDA MEDICAL PRODUCTS CO.,LTD. ROOM 1606 BLDG. 1. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-21
• Decision Date: 2016-03-10
• Summary: summary

NIH GUDID Devices

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