Cleared Traditional

K922495 - SUPER GLOVES(R) HYPOALLERGENIC

K922495 is an FDA 510(k) clearance for SUPER GLOVES HYPOALLERGENIC, manufactured by Taiping Super Holdings Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K922495 · Taiping Super Holdings Sdn Bhd · General Hospital
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Sep 1992
Decision
100d
Days
Class 1
Risk

K922495 is an FDA 510(k) clearance for the SUPER GLOVES(R) HYPOALLERGENIC. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Taiping Super Holdings Sdn Bhd (34007 Taiping, Perak., TW). The FDA issued a Cleared decision on September 4, 1992 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Taiping Super Holdings Sdn Bhd devices

FDA 510(k) Submission Details - K922495

510(k) Number K922495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 04, 1992
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 709
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K922495.
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · Siam Sempermed Corp., Ltd. · Feb 1993
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · Wembley Rubber Products (M) Sdn Bhd · Aug 1992
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992