Cleared Abbreviated

K190782 - FlexGard Cut-Resistant Glove Liners

K190782 is the FDA 510(k) clearance for FlexGard Cut-Resistant Glove Liners by Ldi Corporation. It is a Class 1 General Hospital device (product code KGO) cleared through the Abbreviated 510(k) pathway after a 92-day FDA review.

K190782 · Ldi Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
92d
Days
Class 1
Risk

K190782 is an FDA 510(k) clearance for the FlexGard Cut-Resistant Glove Liners. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ldi Corporation (Portsmouth, US). The FDA issued a Cleared decision on June 27, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Ldi Corporation devices

Submission Details

510(k) Number K190782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2019
Decision Date June 27, 2019
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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

Quality & Regulatory Associates, LLC
Gary Syring

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 - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K190782.
Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
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Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
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Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
K182176 · Pt. Medisafe Technologies · Mar 2019