Cleared Abbreviated

K213076 - AspenMed+ (FDA 510(k) Clearance)

Class I General Hospital device.

K213076 · Aspen Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
88d
Days
Class 1
Risk

K213076 is an FDA 510(k) clearance for the AspenMed+. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Aspen Glove Sdn. Bhd. (Georgetown, MY). The FDA issued a Cleared decision on December 20, 2021 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 880.6250 - 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 K213076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2021
Decision Date December 20, 2021
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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.

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