Cleared Traditional

K200915 - Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K200915 · Gx Corporation Sdn Bhd · General Hospital
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Jul 2021
Decision
459d
Days
Class 1
Risk

K200915 is an FDA 510(k) clearance for the Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Gx Corporation Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on July 9, 2021 after a review of 459 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: 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 Gx Corporation Sdn Bhd devices

Submission Details

510(k) Number K200915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date July 09, 2021
Days to Decision 459 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
331d slower than avg
Panel avg: 128d · This submission: 459d
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 557
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K200915.
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K232079 · Wrp Asia Pacific Sdn. Bhd. · Mar 2024
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K232444 · Grand Work Plastic Products Co., Ltd. · Dec 2023
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K231902 · Ansell Healthcare · Oct 2023
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K231973 · Ineo Tech Sdn Bhd · Sep 2023