Cleared Traditional

K240790 - Polyisoprene Surgical gloves (FDA 510(k) Clearance)

Class I General Hospital device.

K240790 · Suzhou Colour-Way New Material Co., Ltd. · General Hospital
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Aug 2024
Decision
154d
Days
Class 1
Risk

K240790 is an FDA 510(k) clearance for the Polyisoprene Surgical gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Suzhou Colour-Way New Material Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 23, 2024 after a review of 154 days - an extended review cycle.

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 Suzhou Colour-Way New Material Co., Ltd. devices

Submission Details

510(k) Number K240790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2024
Decision Date August 23, 2024
Days to Decision 154 days
Submission Type Traditional
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
26d slower than avg
Panel avg: 128d · This submission: 154d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Eva Li

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 557
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K240790.
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
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
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
K231973 · Ineo Tech Sdn Bhd · Sep 2023
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · Fitone Latex Products Co., Ltd. Guangdong · Sep 2023