Cleared Abbreviated

Sterile Latex Surgical Gloves Powder Free (K211478) - FDA 510(k) Clearance

Class I General Hospital device.

K211478 · Aspen Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
127d
Days
Class 1
Risk

K211478 is an FDA 510(k) clearance for the Sterile Latex Surgical Gloves Powder Free. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Aspen Glove Sdn. Bhd. (Georgetown, MY). The FDA issued a Cleared decision on September 16, 2021 after a review of 127 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 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 Aspen Glove Sdn. Bhd. devices

Submission Details

510(k) Number K211478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2021
Decision Date September 16, 2021
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 K211478.
Nulife
K210969 · Mrk Healthcare Pvt, Ltd. · Nov 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
K211621 · Careplus (M) Sdn Bhd · Oct 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · Cardinal Health200, LLC · Sep 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
K210724 · Careplus (M) Sdn Bhd · Aug 2021
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
K203538 · Medline Industries, Inc. · Aug 2021
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
K200915 · Gx Corporation Sdn Bhd · Jul 2021