Cleared Traditional

K201428 - Powder Free Black Nitrile Examination Glove

K201428 is an FDA 510(k) clearance for Powder Free Black Nitrile Examination Glove, manufactured by Vietglove Corporation. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K201428 · Vietglove Corporation · General Hospital
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Jun 2021
Decision
391d
Days
Class 1
Risk

K201428 is an FDA 510(k) clearance for the Powder Free Black Nitrile Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Vietglove Corporation (Bingh Duong, VN). The FDA issued a Cleared decision on June 24, 2021 after a review of 391 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Vietglove Corporation devices

FDA 510(k) Submission Details - K201428

510(k) Number K201428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date June 24, 2021
Days to Decision 391 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
262d slower than avg
Panel avg: 129d · This submission: 391d
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 701
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K201428.
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587 · Onetexx Sdn Bhd · Jun 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K210775 · Onetexx Sdn Bhd · Jun 2021
Nitrile Glove
K211252 · Jiangsu Dihong Industry and Trade Co., Ltd. · Jun 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
K202085 · Shen Wei (Usa), Inc. · Jun 2021
Powder Free Blue Nitrile Examination Glove
K210375 · Duramitt Sdn Bhd · Jun 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
K211310 · Megine Industries Sdn Bhd · Jun 2021