Cleared Traditional

K894450 - LATEX PATIENT EXAMINATION GLOVES

K894450 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVES, manufactured by Kannex Gloves, Div. of Kanoi Plantations Private. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K894450 · Kannex Gloves, Div. of Kanoi Plantations Private · General Hospital
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Feb 1990
Decision
239d
Days
Class 1
Risk

K894450 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kannex Gloves, Div. of Kanoi Plantations Private (Calcutta-700001, India, IN). The FDA issued a Cleared decision on February 13, 1990 after a review of 239 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Kannex Gloves, Div. of Kanoi Plantations Private devices

FDA 510(k) Submission Details - K894450

510(k) Number K894450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date February 13, 1990
Days to Decision 239 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 722
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K894450.
STERILE LATEX EXAMINATION GLOVE
K900868 · Sri Johani Sdn. Bhd. · Mar 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · Sri Johani Sdn. Bhd. · Mar 1990
UMI BRAIDED CATHETER CONNECTOR
K897128 · Universal Medical Instrument Corp. · Mar 1990
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · Dynarex Corp. · Jan 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990