SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

Polymer Patient Examination Glove

SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD

The following data is part of a premarket notification filed by Shanghai Intco. Plastic & Rubber Products Co., Ltd with the FDA for Synthetic Powder-free Nitrile Patient Examination Gloves.

Pre-market Notification Details

• Device ID: K990186
• 510k Number: K990186
• Device Name: SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
• Classification: Polymer Patient Examination Glove
• Applicant: SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD 13945 MAGNOLIA AVE. Chino, CA 91710
• Contact: Frank Liu
• Correspondent: Frank Liu; SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD 13945 MAGNOLIA 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: 1999-01-20
• Decision Date: 1999-06-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850044458035	K990186	000
20850044458213	K990186	000
10850044458209	K990186	000
10850044458193	K990186	000
10850044458186	K990186	000
20850044458176	K990186	000