POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

Polymer Patient Examination Glove

XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO.,

The following data is part of a premarket notification filed by Xinwei (shandong) Plastic And Rubber Products Co., with the FDA for Powder-free Nitrile Patient Examination Gloves, Blue Color.

Pre-market Notification Details

• Device ID: K121992
• 510k Number: K121992
• Device Name: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
• Classification: Polymer Patient Examination Glove
• Applicant: XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., 12390 EAST END AVE. Chino, CA 91710
• Contact: Frank Liu
• Correspondent: Frank Liu; XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., 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: 2012-07-06
• Decision Date: 2012-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840064620789	K121992	000
00840064620772	K121992	000
00840064620765	K121992	000
00840064620635	K121992	000