Cleared Traditional

K945031 - ROYALSHIELD NON-STERILE POWDER-FREE

K945031 is an FDA 510(k) clearance for ROYALSHIELD NON-STERILE POWDER-FREE, manufactured by Shield Gloves Manufacturer (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945031 · Shield Gloves Manufacturer (M) Sdn Bhd · General Hospital
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Jan 1995
Decision
90d
Days
Class 1
Risk

K945031 is an FDA 510(k) clearance for the ROYALSHIELD NON-STERILE POWDER-FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shield Gloves Manufacturer (M) Sdn Bhd (Petaling Jaya, MY). The FDA issued a Cleared decision on January 11, 1995 after a review of 90 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 Shield Gloves Manufacturer (M) Sdn Bhd devices

FDA 510(k) Submission Details - K945031

510(k) Number K945031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date January 11, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K945031.
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · Sri Johani Sdn. Bhd. · Jan 1995
POWDERFREE LATEX EXAMINATION GLOVES
K932521 · Top Glove Sdn. Bhd. · Dec 1994
LATEX MEDICAL GLOVE
K943900 · Johnson & Johnson Medical, Inc. · Dec 1994