Cleared Special

K192933 - Polyisoprene Powder Free, Black Colour Surgical Gloves (FDA 510(k) Clearance)

Class I General Hospital device.

K192933 · Emerson & Co. Srl · General Hospital
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Jan 2021
Decision
454d
Days
Class 1
Risk

K192933 is an FDA 510(k) clearance for the Polyisoprene Powder Free, Black Colour Surgical Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Emerson & Co. Srl (Genoa, IT). The FDA issued a Cleared decision on January 13, 2021 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Emerson & Co. Srl devices

Submission Details

510(k) Number K192933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2019
Decision Date January 13, 2021
Days to Decision 454 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 128d · This submission: 454d
Pathway characteristics
Modification to existing cleared device.

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 Peers - KGO Surgeon's Gloves

All 557
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K192933.
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
K250313 · Harps Europe Manufacturing GmbH · Aug 2025
Polyisoprene Surgical gloves
K240790 · Suzhou Colour-Way New Material Co., Ltd. · Aug 2024
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
K232079 · Wrp Asia Pacific Sdn. Bhd. · Mar 2024
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
K232444 · Grand Work Plastic Products Co., Ltd. · Dec 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · Ansell Healthcare · Oct 2023
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K231973 · Ineo Tech Sdn Bhd · Sep 2023