Cleared Traditional

K210388 - Non Sterile Nitrile Powder Free Examina...

K210388 is an FDA 510(k) clearance for Non Sterile Nitrile Powder Free Examina..., manufactured by Mexpo International, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K210388 · Mexpo International, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K210388

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.

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 682
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