Cleared Abbreviated

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K193555) - FDA 510(k) Clearance

Class I General Hospital device.

K193555 · Ever Global (Vietnam) Enterprise Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
167d
Days
Class 1
Risk

K193555 is an FDA 510(k) clearance for the Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Ever Global (Vietnam) Enterprise Corp (Dong Nai Province, VN). The FDA issued a Cleared decision on June 4, 2020 after a review of 167 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 Global (Vietnam) Enterprise Corp devices

Submission Details

510(k) Number K193555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date June 04, 2020
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 78
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K193555.
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K222449 · Better Care Plastic Technology Co., Ltd. · Aug 2022
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K220545 · Hl Rubber Industries Sdn Bhd · May 2022
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K220491 · Hainan Asther Medical Equipment Co., Ltd. · May 2022