Cleared Traditional

Disposable Medical Nitrile Examination Gloves (K213912) - FDA 510(k) Clearance

Class I General Hospital device.

K213912 · Jiangsu Maolin Medical Technology Co., Ltd. · General Hospital
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Feb 2022
Decision
66d
Days
Class 1
Risk

K213912 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Maolin Medical Technology Co., Ltd. (Jiangyin, CN). The FDA issued a Cleared decision on February 19, 2022 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jiangsu Maolin Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K213912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2021
Decision Date February 19, 2022
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K213912.
Powder Free Nitrile Examination Gloves (White, Blue and Black)
K212998 · Alcatron Gloves Factory · 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
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
K214110 · Mah Sing Healthcare Sdn. Bhd. · Feb 2022
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
K213306 · Zibo Sinocare Plastic Products Co., Ltd. · Feb 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
K213440 · Luliang Hongruida Health Protection Technology Co., Ltd. · Feb 2022