Cleared Traditional

K954025 - SIME SURGICAL POWDERFREE

K954025 is an FDA 510(k) clearance for SIME SURGICAL POWDERFREE, manufactured by Sime Health, Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K954025 · Sime Health, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
79d
Days
Class 1
Risk

K954025 is an FDA 510(k) clearance for the SIME SURGICAL POWDERFREE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sime Health, Ltd. (Great Neck,, US). The FDA issued a Cleared decision on November 15, 1995 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sime Health, Ltd. devices

FDA 510(k) Submission Details - K954025

510(k) Number K954025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date November 15, 1995
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K954025.
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
K960178 · Wembley Rubber Products (M) Sdn Bhd · May 1996
COMFIT ORTHOPEDIC
K960407 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
COMFIT MICROPTIC
K960416 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
NEUTRALON BROWN LATEX SURGICAL GLOVES
K953639 · Johnson & Johnson Medical, Inc. · Oct 1995
MICRO-TOUCH* LATEX SURGICAL GLOVES
K954049 · Johnson & Johnson Medical, Inc. · Oct 1995
MAXXUS ORTHOPAEDIC SURGICAL GLOVES
K953641 · Johnson & Johnson Medical, Inc. · Sep 1995