Cleared Traditional

Sterile Surgical Powder Free Latex Glove (K221424) - FDA 510(k) Clearance

Class I General Hospital device.

K221424 · New Era Medicare Sdn. Bhd. · General Hospital
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Jan 2023
Decision
255d
Days
Class 1
Risk

K221424 is an FDA 510(k) clearance for the Sterile Surgical Powder Free Latex Glove. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by New Era Medicare Sdn. Bhd. (Teluk Intan, MY). The FDA issued a Cleared decision on January 26, 2023 after a review of 255 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 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 New Era Medicare Sdn. Bhd. devices

Submission Details

510(k) Number K221424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2022
Decision Date January 26, 2023
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K221424.
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
K230217 · Grand Work Plastic Products Co., Ltd. · 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
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K222058 · Wrp Asia Pacific Sdn. Bhd. · Oct 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
K221718 · Hartalega NGC Sdn. Bhd. · Sep 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · Guilin Hbm Health Protections, Inc. · Sep 2022