Cleared Traditional

K013537 - ROYAL IMPERIAL POWDERED LATEX EXAMINATI...

K013537 is an FDA 510(k) clearance for ROYAL IMPERIAL POWDERED LATEX EXAMINATI..., 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 45-day FDA review.

K013537 · Koon Seng Sdn Bhd · General Hospital
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Dec 2001
Decision
45d
Days
Class 1
Risk

K013537 is an FDA 510(k) clearance for the ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELIN.... 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 December 7, 2001 after a review of 45 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 - K013537

510(k) Number K013537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2001
Decision Date December 07, 2001
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 265
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K013537.
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS
K013793 · Shen Wei (Usa), Inc. · Jan 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K013794 · Shen Wei (Usa), Inc. · Jan 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
K013795 · Shen Wei (Usa), Inc. · Jan 2002
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
K013288 · Sgmp Co., Ltd. · Dec 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