Cleared Abbreviated

Sterile Nitrile Surgical Gloves Powder Free (K222350) - FDA 510(k) Clearance

Class I General Hospital device.

K222350 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
253d
Days
Class 1
Risk

K222350 is an FDA 510(k) clearance for the Sterile Nitrile Surgical Gloves Powder Free. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on April 13, 2023 after a review of 253 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Jr Engineering & Medical Technologies (M) Sdn. Bhd. devices

Submission Details

510(k) Number K222350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2022
Decision Date April 13, 2023
Days to Decision 253 days
Submission Type Abbreviated
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
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Standards-based clearance path.

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

Liberty Management Group , Ltd.
Manoj Zacharias

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 K222350.
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 Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
K230217 · Grand Work Plastic Products Co., Ltd. · May 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
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K222058 · Wrp Asia Pacific Sdn. Bhd. · Oct 2022