Cleared Traditional

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K180476) - FDA 510(k) Clearance

Class I General Hospital device.

K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
82d
Days
Class 1
Risk

K180476 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on May 15, 2018 after a review of 82 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 Comfort Rubber Gloves Industries Sdn. Bhd. devices

Submission Details

510(k) Number K180476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2018
Decision Date May 15, 2018
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
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 28
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K180476.
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
K181130 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Aug 2018
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
K173766 · Shen Wei (Usa), Inc. · Jul 2018
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K180646 · Halyard Health · Jun 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
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989