Cleared Traditional

K231973 - PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (FDA 510(k) Clearance)

Class I General Hospital device.

K231973 · Ineo Tech Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
88d
Days
Class 1
Risk

K231973 is an FDA 510(k) clearance for the PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ineo Tech Sdn Bhd (Bandar Kassia, MY). The FDA issued a Cleared decision on September 29, 2023 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ineo Tech Sdn Bhd devices

Submission Details

510(k) Number K231973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date September 29, 2023
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
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 K231973.
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
Polyisoprene Surgical gloves
K240790 · Suzhou Colour-Way New Material Co., Ltd. · Aug 2024
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
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · Fitone Latex Products Co., Ltd. Guangdong · Sep 2023