Cleared Traditional

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs (K183562) - FDA 510(k) Clearance

Class I General Hospital device.

K183562 · Encompass Industries Sdn. Bhd. · General Hospital
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Oct 2019
Decision
307d
Days
Class 1
Risk

K183562 is an FDA 510(k) clearance for the Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Encompass Industries Sdn. Bhd. (Kemaman, MY). The FDA issued a Cleared decision on October 23, 2019 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Encompass Industries Sdn. Bhd. devices

Submission Details

510(k) Number K183562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date October 23, 2019
Days to Decision 307 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 129d · This submission: 307d
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 K183562.
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
K201390 · Medline Industires, Inc. · Sep 2020
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
K193555 · Ever Global (Vietnam) Enterprise Corp · Jun 2020
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
K191230 · O&M Halyard, Inc. · Nov 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
K182382 · Gmp Medicare Sdn Bhd (F25) · Aug 2019
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
K183149 · Central Medicare Sdn Bhd · Jul 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
K190159 · Showa Best Glove, Inc. · May 2019