Cleared Traditional

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color (K210388) - FDA 510(k) Clearance

Class I General Hospital device.

K210388 · Mexpo International, Inc. · General Hospital
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Dec 2021
Decision
307d
Days
Class 1
Risk

K210388 is an FDA 510(k) clearance for the Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Mexpo International, Inc. (Union City, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mexpo International, Inc. devices

Submission Details

510(k) Number K210388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2021
Decision Date December 13, 2021
Days to Decision 307 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
178d slower than avg
Panel avg: 129d · This submission: 307d
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 K210388.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
K212898 · Rimba Glove Snd Bhd · Dec 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919 · Jiujiang Taixin Technology Co., Ltd. · Dec 2021
Nitrile Examination Gloves (Powder free, Blue)
K213029 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Dec 2021
Nitrile Examination Gloves
K212924 · Shanxi Nacosa Medical Technology Co.,Ltd · Dec 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Dec 2021
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085 · Siam Ntd Corporation Co., Ltd. · Dec 2021