Nulife

Surgeon's Gloves

MRK Healthcare Pvt Ltd

The following data is part of a premarket notification filed by Mrk Healthcare Pvt Ltd with the FDA for Nulife.

Pre-market Notification Details

• Device ID: K210969
• 510k Number: K210969
• Device Name: Nulife
• Classification: Surgeon's Gloves
• Applicant: MRK Healthcare Pvt Ltd S.No.153/P&310,Panch, Pippal, Hansapur, Runi, Unjha-Patan Road Patan, IN 384265
• Contact: Anil R Dave
• Correspondent: Manoj Zacharias; Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, IL 60504
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-31
• Decision Date: 2021-11-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08905159001811	K210969	000
08905159002139	K210969	000
08905159002146	K210969	000
08905159002153	K210969	000
08905159002160	K210969	000
08905159002177	K210969	000
08905159002184	K210969	000
08905159002191	K210969	000
08905159002207	K210969	000
08905159002214	K210969	000
08905159002221	K210969	000
08905159001743	K210969	000
08905159001750	K210969	000
08905159001767	K210969	000
08905159001774	K210969	000
08905159001781	K210969	000
08905159001798	K210969	000
08905159001804	K210969	000
08905159002122	K210969	000