Cleared Traditional

K210588 - Black Nitrile Powder Free Patient Exami...

K210588 is an FDA 510(k) clearance for Black Nitrile Powder Free Patient Exami..., manufactured by Onetexx Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K210588 · Onetexx Sdn Bhd · General Hospital
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Oct 2021
Decision
247d
Days
Class 1
Risk

K210588 is an FDA 510(k) clearance for the Black Nitrile Powder Free Patient Examination Glove, Non Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Onetexx Sdn Bhd (Kamunting, MY). The FDA issued a Cleared decision on October 31, 2021 after a review of 247 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 Onetexx Sdn Bhd devices

FDA 510(k) Submission Details - K210588

510(k) Number K210588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2021
Decision Date October 31, 2021
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
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 K210588.
Disposable Nitrile Examination Glove
K212467 · Inner Mongolia Boming Medical Supplies Co., Ltd. · Nov 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210777 · Shandong Jieshi Medical Products Co., Ltd. · Nov 2021
Nitrile Examination Gloves (Blue, Violet)
K211586 · Lyncmed Medical Technology (Beijing) Co., Ltd. · Nov 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
K212308 · Srirungruang Global Co., Ltd. · Oct 2021
Disposable Nitrile Examination Gloves (Powder free, Blue)
K211581 · Leping Shengde Medical Technology Company Limited · Oct 2021
Examination gloves -Type C (Nitrile gloves)
K212290 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Oct 2021