Cleared Traditional

K121844 - POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

K121844 is an FDA 510(k) clearance for POWDER FREE NATURAL RUBBER LATEX EXAMIN..., manufactured by Worldmed Manufacturing Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 438-day FDA review.

K121844 · Worldmed Manufacturing Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
438d
Days
Class 1
Risk

K121844 is an FDA 510(k) clearance for the POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Worldmed Manufacturing Sdn. Bhd. (Kamunting, MY). The FDA issued a Cleared decision on September 6, 2013 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Worldmed Manufacturing Sdn. Bhd. devices

FDA 510(k) Submission Details - K121844

510(k) Number K121844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2012
Decision Date September 06, 2013
Days to Decision 438 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 129d · This submission: 438d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 Peers - LYY Latex Patient Examination Glove

All 388
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K121844.
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