Cleared Traditional

K012714 - ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

K012714 is an FDA 510(k) clearance for ROYAL IMPERIAL POWDER FREE POLYMER COAT..., 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 78-day FDA review.

K012714 · Koon Seng Sdn Bhd · General Hospital
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Oct 2001
Decision
78d
Days
Class 1
Risk

K012714 is an FDA 510(k) clearance for the ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Koon Seng Sdn Bhd (Muar, Johor, MY). The FDA issued a Cleared decision on October 31, 2001 after a review of 78 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 - K012714

510(k) Number K012714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date October 31, 2001
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 782
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K012714.
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
K013443 · Maxter Glove Manufacturing Sdn Bhd · Nov 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · Smart Glove Corp. Sdn Bhd · Nov 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · Kimberly-Clark Corp. · Nov 2001
POWDERED LATEX EXAMINATION GLOVES
K013026 · Great Glove (Thailand) Co. , Ltd. · Oct 2001
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
K012402 · Omnigrace (Thailand) , Ltd. · Oct 2001
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA
K013286 · Tillotson Healthcare Corp. · Oct 2001