Cleared Traditional

K212998 - Powder Free Nitrile Examination Gloves ...

K212998 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Alcatron Gloves Factory. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K212998 · Alcatron Gloves Factory · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K212998

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.

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 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