Cleared Traditional

POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE (K093500) - FDA 510(k) Clearance

Class I General Hospital device.

K093500 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
68d
Days
Class 1
Risk

K093500 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED).... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Klang, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on January 19, 2010 after a review of 68 days - a notably fast clearance 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: 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 Wear Safe Malaysia Sdn. Bhd. devices

Submission Details

510(k) Number K093500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2009
Decision Date January 19, 2010
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 30
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K093500.
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · May 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172864 · Maxter Glove Manufacturing Sdn Bhd · May 2018
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K173942 · Central Medicare Sdn Bhd · Mar 2018
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089 · Kimberly-Clark Corp. · Jul 2008
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989