Cleared Traditional

Powder Free Blue Nitrile Examination Gloves (K213678) - FDA 510(k) Clearance

Class I General Hospital device.

K213678 · Lienteh Technology Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 489
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