Summit Glove, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Summit Glove, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit), Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit), Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
5
Total
5
Cleared
0
Denied
Summit Glove, Inc. has 5 FDA 510(k) cleared medical devices. Based in Minerva, US.
Last cleared in 2022. Active since 2010. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Summit Glove, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Truscott Medsci Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Summit Glove, Inc.
5 devices
Cleared
Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...
General Hospital
266d
Cleared
Apr 13, 2022
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip...
General Hospital
63d
Cleared
Apr 13, 2022
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips,...
General Hospital
63d
Cleared
Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION...
General Hospital
228d
Cleared
Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT...
General Hospital
228d