Cleared Abbreviated

K151114 - Medismart ( Latex Surgeon¿s Gloves powd...

K151114 is an FDA 510(k) clearance for Medismart ( Latex Surgeon¿s Gloves powd..., manufactured by St. Marys Rubbers Pvt, Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 228-day FDA review.

K151114 · St. Marys Rubbers Pvt, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
228d
Days
Class 1
Risk

K151114 is an FDA 510(k) clearance for the Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by St. Marys Rubbers Pvt, Ltd. (Kottayam District, Kerala, IN). The FDA issued a Cleared decision on December 11, 2015 after a review of 228 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all St. Marys Rubbers Pvt, Ltd. devices

FDA 510(k) Submission Details - K151114

510(k) Number K151114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2015
Decision Date December 11, 2015
Days to Decision 228 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 129d · This submission: 228d
Pathway characteristics
Standards-based clearance path.

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 275
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K151114.
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Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
K142941 · Pt. Medisafe Technologies · Nov 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
K151392 · Terang Nusa Sdn Bhd · Sep 2015