Cleared Traditional

Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim (K220943) - FDA 510(k) Clearance

Class I General Hospital device.

K220943 · Eco Medi Glove Sdn. Bhd. · General Hospital
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Jul 2022
Decision
110d
Days
Class 1
Risk

K220943 is an FDA 510(k) clearance for the Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eco Medi Glove Sdn. Bhd. (Taiping, MY). The FDA issued a Cleared decision on July 19, 2022 after a review of 110 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 Eco Medi Glove Sdn. Bhd. devices

Submission Details

510(k) Number K220943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2022
Decision Date July 19, 2022
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
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 K220943.
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K221269 · Better Care Plastic Technology Co., Ltd. · Jul 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221271 · Shandong Maida Medical Technology Co., Ltd. · Jul 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877 · Goodgloves Industries Sdn Bhd · Jul 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
K221229 · Zibo Blue Sail Health Technology Co., Ltd. · Jul 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574 · Grand Work Plastic Products Co., Ltd. · Jul 2022
Nitrile Medical Examination Gloves
K221108 · Anhui Fulewei Electronic Technology Co.,Ltd · Jul 2022