Cleared Traditional

K213678 - Powder Free Blue Nitrile Examination Gloves

K213678 is an FDA 510(k) clearance for Powder Free Blue Nitrile Examination Gloves, manufactured by Lienteh Technology Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K213678 · Lienteh Technology Sdn Bhd · General Hospital
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Mar 2022
Decision
120d
Days
Class 1
Risk

K213678 is an FDA 510(k) clearance for the Powder Free Blue Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Lienteh Technology Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on March 22, 2022 after a review of 120 days - within the typical 510(k) review window.

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 Lienteh Technology Sdn Bhd devices

FDA 510(k) Submission Details - K213678

510(k) Number K213678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date March 22, 2022
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K213678.
Medical nitrile examination gloves (Model: JL001)
K213848 · Guangdong Jiali Pharmaceutical Co.,Ltd · Mar 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K212916 · Rimba Glove Sdn Bhd · Mar 2022
Disposable Medical Synthetic Nitrile Examination Gloves
K220354 · Niujian Technology Co., Ltd. · Mar 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
K220228 · Shandong Blue Sail Health Technology Co., Ltd. · Mar 2022
Disposable Nitrile Examination Glove
K213121 · Jiangsu Cureguard Glove Co., Ltd. · Mar 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
K212148 · Ansell Healthcare Products, LLC · Mar 2022