Cleared Traditional

K121591 - FLAVORED POWDER FREE AND POLYMER COATED...

K121591 is the FDA 510(k) clearance for FLAVORED POWDER FREE AND POLYMER COATED... by Tekmedic (M) Sdn Bhd. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K121591 · Tekmedic (M) Sdn Bhd · General Hospital
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Oct 2012
Decision
133d
Days
Class 1
Risk

K121591 is an FDA 510(k) clearance for the FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tekmedic (M) Sdn Bhd (Jetty, Tanjung Kling, Malacca, MY). The FDA issued a Cleared decision on October 11, 2012 after a review of 133 days - within the typical 510(k) review window.

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: 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 Tekmedic (M) Sdn Bhd devices

Submission Details

510(k) Number K121591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date October 11, 2012
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 Peers - LYY Latex Patient Examination Glove

All 125
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K121591.
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006 · Hartalega Sdn Bhd · Aug 2016
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953 · Hartalega Sdn Bhd · May 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368 · Hartalega Sdn Bhd · May 2013
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · Hartalega Sdn Bhd · Jun 2005