Cleared Traditional

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378) - FDA 510(k) Clearance

Class I General Hospital device.

K221378 · Tec Gloves Industry (M) Sdn.Bhd. · General Hospital
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Sep 2022
Decision
141d
Days
Class 1
Risk

K221378 is an FDA 510(k) clearance for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tec Gloves Industry (M) Sdn.Bhd. (Klang, MY). The FDA issued a Cleared decision on September 30, 2022 after a review of 141 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 Tec Gloves Industry (M) Sdn.Bhd. devices

Submission Details

510(k) Number K221378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2022
Decision Date September 30, 2022
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 K221378.
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
K222074 · Zibo Langu New Material Technology Co., Ltd. · Oct 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
K222714 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Oct 2022
Disposable Nitrile Examination Glove
K222937 · Jiangsu Cureguard Glove Co., Ltd. · Oct 2022
Powder Free Nitrile Examination Glove
K212751 · Dainam Glove Joint Stock Company · Sep 2022
Nitrile Examination Glove, Pink Color
K221887 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Sep 2022
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
K222294 · Onetexx Sdn Bhd · Sep 2022