Cleared Traditional

K213500 - TMG Nitrile Powder Free Examination Glove

K213500 is an FDA 510(k) clearance for TMG Nitrile Powder Free Examination Glove, manufactured by Thai Medical Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K213500 · Thai Medical Glove Co., Ltd. · General Hospital
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Feb 2022
Decision
112d
Days
Class 1
Risk

K213500 is an FDA 510(k) clearance for the TMG Nitrile Powder Free Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Thai Medical Glove Co., Ltd. (Sriracha, TH). The FDA issued a Cleared decision on February 21, 2022 after a review of 112 days - within the typical 510(k) review window.

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 Thai Medical Glove Co., Ltd. devices

FDA 510(k) Submission Details - K213500

510(k) Number K213500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date February 21, 2022
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 K213500.
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K210330 · Wrp Asia Pacific Sdn. Bhd. · Mar 2022
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
K211808 · Dongguan Grinvald Technology Co., Ltd. · Mar 2022
Disposable Nitrile Examination Gloves
K212833 · Chifeng Huawei Medical Science&Technology 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
Powder Free Nitrile Examination Gloves (White, Blue and Black)
K212998 · Alcatron Gloves Factory · Feb 2022