Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

Surgeon's Gloves

Molnlycke Health Care, US LLC

The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Biogel® Pi Ultratouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove.

Pre-market Notification Details

• Device ID: K190077
• 510k Number: K190077
• Device Name: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
• Classification: Surgeon's Gloves
• Applicant: Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092
• Contact: Leonard Stewart
• Correspondent: Leonard Stewart; Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-16
• Decision Date: 2019-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07323190240371	K190077	000
07323190239429	K190077	000
07323190239474	K190077	000
07323190239511	K190077	000
07323190239573	K190077	000
07323190239627	K190077	000
07323190239672	K190077	000
07323190239719	K190077	000
07323190235070	K190077	000
07323190240067	K190077	000
07323190240111	K190077	000
07323190240173	K190077	000
07323190240227	K190077	000
07323190240265	K190077	000
07323190240319	K190077	000
07323190239054	K190077	000