Cleared Traditional

K012714 - ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (FDA 510(k) Clearance)

Class I General Hospital device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K012714.
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
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Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
K230573 · Kossan International Sdn Bhd · Jun 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
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K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022