Cleared Traditional

Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs (K222993) - FDA 510(k) Clearance

Also marketed or referenced as:
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs

Class I General Hospital device.

K222993 · Sentienx Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
324d
Days
Class 1
Risk

K222993 is an FDA 510(k) clearance for the Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Gre.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sentienx Sdn Bhd (Kulim, MY). The FDA issued a Cleared decision on August 18, 2023 after a review of 324 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. 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. Elevated predicate reliance profile. 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 Sentienx Sdn Bhd devices

Submission Details

510(k) Number K222993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2022
Decision Date August 18, 2023
Days to Decision 324 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
195d slower than avg
Panel avg: 129d · This submission: 324d
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

Tg Medical USA (Inc)
David Lim

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 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K222993.
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · Fitone Latex Products Co., Ltd. Guangdong · Sep 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
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
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
K230832 · The Egyptian Company For Medical & Electronic Industries · Aug 2023
Polyisoprene Surgical Gloves
K230304 · Puyang Linshi Medical Supplies Co., Ltd. · Aug 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · Ansell Healthcare Products, LLC · May 2023