Cleared Traditional

Iconic Latex Glove (K221648) - FDA 510(k) Clearance

Class I General Hospital device.

K221648 · Iconic Medicare Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
79d
Days
Class 1
Risk

K221648 is an FDA 510(k) clearance for the Iconic Latex Glove. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Iconic Medicare Sdn Bhd (Batu Kawan, MY). The FDA issued a Cleared decision on August 25, 2022 after a review of 79 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iconic Medicare Sdn Bhd devices

Submission Details

510(k) Number K221648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date August 25, 2022
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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

Integrated Assessment Services Pvt, Ltd.
A.C. Thirumaran

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 - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K221648.
JR MEDIC
K222348 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Oct 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
K221374 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Oct 2022
Single-use medical latex examination gloves (LG100)
K222693 · Fitone Latex Products Co., Ltd. Guangdong · Sep 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · Wrp Asia Pacific Sdn. Bhd. · Aug 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
K212482 · Sri Trang Gloves (Thailand) Public Company Limited · Aug 2022
Examination gloves-Type A(Latex gloves)
K214017 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Jul 2022