Cleared Traditional

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (K230217) - FDA 510(k) Clearance

Class I General Hospital device.

K230217 · Grand Work Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
107d
Days
Class 1
Risk

K230217 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemothe.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Grand Work Plastic Products Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on May 13, 2023 after a review of 107 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 Grand Work Plastic Products Co., Ltd. devices

Submission Details

510(k) Number K230217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2023
Decision Date May 13, 2023
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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

Hongray USA Medical Products, Inc.
Kathy Liu

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 K230217.
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
Sterile Nitrile Surgical Gloves Powder Free
K222350 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Apr 2023
Sterilized Latex Surgical Gloves
K222620 · Suzhou Colour-Way New Material Co., Ltd. · Mar 2023
Sterile Surgical Powder Free Latex Glove
K221424 · New Era Medicare Sdn. Bhd. · Jan 2023