Cleared Traditional

K220943 - Dual Color Blue/White Powder Free Nitri...

K220943 is an FDA 510(k) clearance for Dual Color Blue/White Powder Free Nitri..., manufactured by Eco Medi Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

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

FDA 510(k) Submission Details - K220943

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.

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 K220943.
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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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
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K213574 · Grand Work Plastic Products Co., Ltd. · Jul 2022
Nitrile Medical Examination Gloves
K221108 · Anhui Fulewei Electronic Technology Co.,Ltd · Jul 2022