Cleared Traditional

K182528 - Nitrile Glove Powder Free Black (FDA 510(k) Clearance)

Class I General Hospital device.

K182528 · Haining Medical Products Co., Ltd. · General Hospital
Nov 2018
Decision
62d
Days
Class 1
Risk

K182528 is an FDA 510(k) clearance for the Nitrile Glove Powder Free Black. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Haining Medical Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on November 15, 2018 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K182528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2018
Decision Date November 15, 2018
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 169d · This submission: 62d
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 50
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K182528.
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