Cleared Traditional

K071322 - POWDER FREE LATEX EXAMINATION GLOVES

K071322 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Quality Gallant Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K071322 · Quality Gallant Sdn. Bhd. · General Hospital
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Jul 2007
Decision
64d
Days
Class 1
Risk

K071322 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Quality Gallant Sdn. Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on July 13, 2007 after a review of 64 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 - K071322

510(k) Number K071322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2007
Decision Date July 13, 2007
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 1349
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K071322.
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
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
K071209 · High Momentum 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
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
K070821 · Medtexx Manufacturing Sdn. Bhd. · May 2007
K071322 · POWDER FREE LATEX EXAMINATION GLOVES
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