Cleared Traditional

K170515 - Sterile Nitrile Surgical Gloves

K170515 is an FDA 510(k) clearance for Sterile Nitrile Surgical Gloves, manufactured by Primus Gloves Pvt Limited. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K170515 · Primus Gloves Pvt Limited · General Hospital
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Jun 2017
Decision
108d
Days
Class 1
Risk

K170515 is an FDA 510(k) clearance for the Sterile Nitrile Surgical Gloves, Powder-free. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Primus Gloves Pvt Limited (Cochin, IN). The FDA issued a Cleared decision on June 9, 2017 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Primus Gloves Pvt Limited devices

FDA 510(k) Submission Details - K170515

510(k) Number K170515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date June 09, 2017
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 272
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K170515.
Gammex PI Breach Detect Powder Free Surgical Glove
K171375 · Ansell Healthcare Products, LLC · Feb 2018
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
K172942 · Beta Healthcare Products Pvt., Ltd. · Jan 2018
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
K170198 · Cardinal Health, Inc. · Jun 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · Hartalega Sdn Bhd · May 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
K161823 · Wrp Asia Pacific Sdn. Bhd. · Jan 2017
Gammex Cut-Resistant Glove Liner
K160974 · Ansell Healthcare Products, LLC · Oct 2016