Cleared Traditional

K093375 - KS-CARE POWDER FREE POLYMER COATED LATE...

K093375 is an FDA 510(k) clearance for KS-CARE POWDER FREE POLYMER COATED LATE..., manufactured by Koon Seng Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K093375 · Koon Seng Sdn Bhd · General Hospital
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Dec 2009
Decision
34d
Days
Class 1
Risk

K093375 is an FDA 510(k) clearance for the KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTE.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Koon Seng Sdn Bhd (Great Neck, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 34 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 Koon Seng Sdn Bhd devices

FDA 510(k) Submission Details - K093375

510(k) Number K093375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2009
Decision Date December 02, 2009
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 265
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K093375.
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
K100907 · Siam Sempermed Corp., Ltd. · Jul 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
K083337 · Terang Nusa Sdn Bhd · Jan 2009
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · Siam Sempermed Corp., Ltd. · Sep 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K081907 · Siam Sempermed Corp., Ltd. · Sep 2008