Cleared Traditional

K090327 - POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE

K090327 is an FDA 510(k) clearance for POWDER FREE POLYMER COATED LATEX EXAMIN..., manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K090327 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
53d
Days
Class 1
Risk

K090327 is an FDA 510(k) clearance for the POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on April 3, 2009 after a review of 53 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.

FDA 510(k) Submission Details - K090327

510(k) Number K090327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2009
Decision Date April 03, 2009
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 1134
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K090327.
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
K092492 · Wear Safe Malaysia Sdn. Bhd. · Oct 2009
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
K083571 · Purna Bina Sdn Bhd · Aug 2009
ALATECH POWDER FREE LATEX EXAMINATION GLOVE
K083761 · Alatech Healthcare, LLC · Jul 2009
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