Cleared Traditional

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (K201857) - FDA 510(k) Clearance

Class I General Hospital device.

K201857 · Careplus (M) Sdn Bhd · General Hospital
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Aug 2021
Decision
410d
Days
Class 1
Risk

K201857 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove Black and Dual Color White-Blue. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on August 20, 2021 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Careplus (M) Sdn Bhd devices

Submission Details

510(k) Number K201857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date August 20, 2021
Days to Decision 410 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
281d slower than avg
Panel avg: 129d · This submission: 410d
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 K201857.
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
K210898 · Tangshan Lanhai Medical Supplies Co., Ltd. · Aug 2021
Disposable Nitrile Examination Gloves
K210897 · Shandong DS Safety Technology Co., Ltd. · Aug 2021
Nitrile Examination Gloves
K211515 · Beijing Reagent Latex Products Co., Ltd. · Aug 2021
Medical Gloves
K203622 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Aug 2021
Nitrile Exam Gloves, Powder Free, Blue
K211699 · Hengchang (Dongying) Medical Technology Co., Ltd. · Aug 2021
Purism Non-Sterile Powder Free Nitrile Examination Gloves
K211319 · Dezhou Purism Medical Technology Co., Ltd. · Aug 2021