Cleared Traditional

K121594 - COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)

K121594 is an FDA 510(k) clearance for COLORED POWDER FREE LATEX EXAMINATION G..., manufactured by Tekmedic (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K121594 · Tekmedic (M) Sdn Bhd · General Hospital
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Oct 2012
Decision
147d
Days
Class 1
Risk

K121594 is an FDA 510(k) clearance for the COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE). 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 25, 2012 after a review of 147 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

FDA 510(k) Submission Details - K121594

510(k) Number K121594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date October 25, 2012
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 618
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K121594.
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
K123757 · Assurguard Sdn. Bhd. · Feb 2013
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
K122788 · Northstar Healthcare Holdings · Jan 2013
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
K123026 · Northstar Healthcare Holdings · Nov 2012
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
K121591 · Tekmedic (M) Sdn Bhd · Oct 2012
NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
K112693 · Sgmp Co., Ltd. · Sep 2012
POWDER FREE LATEX EXAMINATION GLOVES
K113685 · Khai Hoan Joint Stock Company · Aug 2012