Cleared Traditional

K210868 - Nitrile Examination Gloves Powder Free ...

K210868 is an FDA 510(k) clearance for Nitrile Examination Gloves Powder Free ..., manufactured by Great Eco 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 163-day FDA review.

K210868 · Great Eco Glove Sdn. Bhd. · General Hospital
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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

FDA 510(k) Submission Details - K210868

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.

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 687
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