Cleared Traditional

K071209 - MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES

K071209 is an FDA 510(k) clearance for MASTER GUARD LATEX POWDER FREE EXAMINAT..., manufactured by High Momentum Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K071209 · High Momentum Sdn Bhd · General Hospital
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Jul 2007
Decision
85d
Days
Class 1
Risk

K071209 is an FDA 510(k) clearance for the MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by High Momentum Sdn Bhd (Selangor Daurl Ehsan, MY). The FDA issued a Cleared decision on July 25, 2007 after a review of 85 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 - K071209

510(k) Number K071209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2007
Decision Date July 25, 2007
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K071209.
MEDICAL GLOVE SERIES
K072145 · Zhanjiang Jiali Glove Products Co., Ltd. · Feb 2008
YUYUAN LATEX EXAMINATION GLOVE, POWDERED
K072639 · Shandong Yuyuan Latex Gloves Company , Ltd. · Nov 2007
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
K071060 · Sgmp Co., Ltd. · Jul 2007
POWDER FREE LATEX EXAMINATION GLOVES
K071322 · Quality Gallant Sdn. Bhd. · Jul 2007
POWDERED LATEX EXAMINATION GLOVES
K071323 · Quality Gallant Sdn. Bhd. · Jun 2007
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
K070760 · Derma Care Plus Products, LLC · Jun 2007
K071209 · MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
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