Cleared Traditional

Powder Free Nitrile Examination Gloves (White, Blue and Black) (K212998) - FDA 510(k) Clearance

Class I General Hospital device.

K212998 · Alcatron Gloves Factory · General Hospital
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Feb 2022
Decision
152d
Days
Class 1
Risk

K212998 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (White, Blue and Black). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Alcatron Gloves Factory (Weifang, CN). The FDA issued a Cleared decision on February 19, 2022 after a review of 152 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 Alcatron Gloves Factory devices

Submission Details

510(k) Number K212998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date February 19, 2022
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 K212998.
TMG Nitrile Powder Free Examination Glove
K213500 · Thai Medical Glove Co., Ltd. · Feb 2022
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
K213548 · Mercator Medical (Thailand), Ltd. · Feb 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232 · Megine Industries Sdn Bhd · Feb 2022
EONS Nitrile Examination Gloves Powder Free
K213286 · Eons Gloves (Thailand) Co., Ltd. · Feb 2022
Medical nitrile examination gloves (Model: SH001)
K213600 · Jiangxi Sanhao Medical Instruments Co.,Ltd · Feb 2022
Disposable Medical Nitrile Examination Gloves
K213912 · Jiangsu Maolin Medical Technology Co., Ltd. · Feb 2022