Cleared Traditional

Nitrile Examination Gloves Powder Free (Blue) (K210868) - FDA 510(k) Clearance

Class I General Hospital device.

K210868 · Great Eco Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
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Sep 2021
Decision
163d
Days
Class 1
Risk

K210868 is an FDA 510(k) clearance for the Nitrile Examination Gloves Powder Free (Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Great Eco Glove Sdn. Bhd. (Bestari Jaya, MY). The FDA issued a Cleared decision on September 2, 2021 after a review of 163 days - an extended review cycle.

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 Great Eco Glove Sdn. Bhd. devices

Submission Details

510(k) Number K210868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2021
Decision Date September 02, 2021
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 K210868.
Disposable Nitrile Examination Gloves
K211073 · Foshan Kangkang Biotechnology Co., Ltd. · Sep 2021
Blue Nitrile Examination Glove Powder Free
K211479 · Aspen Glove Sdn. Bhd. · Sep 2021
Disposable Nitrile Gloves
K212009 · Jiangsu Shenglijie Safety Products Co., Ltd. · Sep 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778 · Zhenjiang Suhui Latex Products Co., Ltd. · Sep 2021
Disposable Medical Nitrile Gloves
K211673 · Changzhou Yihua Sanitation Material Co., Ltd. · Sep 2021
Nitrile Blue Powder-free Examination Glove
K211390 · Cardinal Health200, LLC · Aug 2021