Cleared Traditional

K926132 - ROYAL SHIELD SHIELD GLOVES

K926132 is an FDA 510(k) clearance for ROYAL SHIELD SHIELD GLOVES, manufactured by Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K926132 · Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · General Hospital
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Dec 1993
Decision
380d
Days
Class 1
Risk

K926132 is an FDA 510(k) clearance for the ROYAL SHIELD SHIELD GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on December 22, 1993 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. devices

FDA 510(k) Submission Details - K926132

510(k) Number K926132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date December 22, 1993
Days to Decision 380 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
251d slower than avg
Panel avg: 129d · This submission: 380d
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 705
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K926132.
COMFIT
K933263 · Wembley Rubber Products (M) Sdn Bhd · Feb 1994
COMFIT GREEN POWDER FREE EXAMINATION GLOVE
K934812 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
COMFIT BLUE POWDER FREE EXAMINATION GLOVE
K934813 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
DIGITEX, DIGITEX HYPOALLERGENIC
K926049 · Mayer Laboratories · Jul 1993
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993