Cleared Traditional

K891160 - MIC NON-STERILE LATEX GLOVES

K891160 is an FDA 510(k) clearance for MIC NON-STERILE LATEX GLOVES, manufactured by Asia Dynamics, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K891160 · Asia Dynamics, Inc. · General Hospital
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Oct 1989
Decision
221d
Days
Class 1
Risk

K891160 is an FDA 510(k) clearance for the MIC NON-STERILE LATEX GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Asia Dynamics, Inc. (Chicago, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 221 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 Asia Dynamics, Inc. devices

FDA 510(k) Submission Details - K891160

510(k) Number K891160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date October 13, 1989
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 226
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891160.
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · Ansell, Inc. · Aug 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · Baxter Healthcare Corp · Aug 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE
K891791 · Medline Industries, Inc. · Jul 1989