Cleared Traditional

Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) - FDA 510(k) Clearance

Class I General Hospital device.

K231446 · Fitone Latex Products Co., Ltd. Guangdong · General Hospital
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Sep 2023
Decision
127d
Days
Class 1
Risk

K231446 is an FDA 510(k) clearance for the Single-Use Latex Sterile Surgical Gloves (SG100). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Fitone Latex Products Co., Ltd. Guangdong (Zhanjiang, CN). The FDA issued a Cleared decision on September 22, 2023 after a review of 127 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Fitone Latex Products Co., Ltd. Guangdong devices

Submission Details

510(k) Number K231446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2023
Decision Date September 22, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

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 K231446.
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K230578 · Wrp Asia Pacific Sdn. Bhd. · Aug 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
K230079 · Ansell Healthcare Products, LLC · Aug 2023
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs
K222993 · Sentienx Sdn Bhd · Aug 2023