Cleared Special

Polyisoprene Powder Free, Black Colour Surgical Gloves (K192933) - 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
325d slower than avg
Panel avg: 129d · 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 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K192933.
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
K202765 · Careplus (M) Sdn Bhd · May 2021
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
K202401 · Eco Medi Glove Sdn. Bhd. · Feb 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · Guilin Hbm Health Protections, Inc. · Feb 2021
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
K202668 · Medline Industries, Inc. · Dec 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
K202090 · Molnlycke Health Care Us, LLC · Nov 2020
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
K202449 · Medline Industries, Inc. · Nov 2020