Nitrile Disposable Examination Gloves

Polymer Patient Examination Glove

Xingyu Medical Tech Co., Ltd.

The following data is part of a premarket notification filed by Xingyu Medical Tech Co., Ltd. with the FDA for Nitrile Disposable Examination Gloves.

Pre-market Notification Details

• Device ID: K212578
• 510k Number: K212578
• Device Name: Nitrile Disposable Examination Gloves
• Classification: Polymer Patient Examination Glove
• Applicant: Xingyu Medical Tech Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone Weifang, CN
• Contact: Cathrine Luan
• Correspondent: Eva Li; Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, CN 200122
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-16
• Decision Date: 2021-12-02

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