Cleared Traditional

K182383 - Non-Sterile

K182383 is the FDA 510(k) clearance for Non-Sterile by Yty Industry (Manjung) Sdn Bhd. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K182383 · Yty Industry (Manjung) Sdn Bhd · General Hospital
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Mar 2019
Decision
200d
Days
Class 1
Risk

K182383 is an FDA 510(k) clearance for the Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Sitiawan, MY). The FDA issued a Cleared decision on March 19, 2019 after a review of 200 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 Yty Industry (Manjung) Sdn Bhd devices

Submission Details

510(k) Number K182383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2018
Decision Date March 19, 2019
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
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 40
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K182383.
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
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K183132 · O&M Halyard, Inc. · Feb 2019
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