Cleared Traditional

K940797 - SIME SURGICAL LATEX GLOVE

K940797 is an FDA 510(k) clearance for SIME SURGICAL LATEX GLOVE, 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 76-day FDA review.

K940797 · Sime Health, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
76d
Days
Class 1
Risk

K940797 is an FDA 510(k) clearance for the SIME SURGICAL LATEX GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sime Health, Ltd. (Seattle, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 76 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 - K940797

510(k) Number K940797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date May 09, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K940797.
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · Baxter Healthcare Corp · Jul 1994
SURESOFT SURGICAL GLOVES
K940218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
COMFIT
K935464 · Wembley Rubber Products (M) Sdn Bhd · May 1994
MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES
K935227 · Johnson & Johnson Medical, Inc. · Mar 1994
DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
K935869 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS
K935870 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994