Cleared Abbreviated

K190942 - Disposable Powder Free Nitrile Examinat...

K190942 is the FDA 510(k) clearance for Disposable Powder Free Nitrile Examinat... by Ever Growth (Vietnam) Co. , Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 272-day FDA review.

K190942 · Ever Growth (Vietnam) Co. , Ltd. · General Hospital
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Jan 2020
Decision
272d
Days
Class 1
Risk

K190942 is an FDA 510(k) clearance for the Disposable Powder Free Nitrile Examination Glove, Pink/Black Color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ever Growth (Vietnam) Co. , Ltd. (Binhloc Village, VN). The FDA issued a Cleared decision on January 7, 2020 after a review of 272 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ever Growth (Vietnam) Co. , Ltd. devices

Submission Details

510(k) Number K190942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2019
Decision Date January 07, 2020
Days to Decision 272 days
Submission Type Abbreviated
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
143d slower than avg
Panel avg: 129d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Elizabeth Deng
Elizabeth Deng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K190942.
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K192333 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Jan 2020
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
K192635 · Wrp Asia Pacific Sdn. Bhd. · Jan 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K192315 · Medline Industries, Inc. · Jan 2020
mCare® Powder Free Nitrile Black Examination Glove
K192444 · Mercator Medical (Thailand), Ltd. · Dec 2019
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
K190736 · Ever Growth (Vietnam) Co. , Ltd. · Dec 2019
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
K190860 · Ever Growth (Vietnam) Co. , Ltd. · Dec 2019