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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 1238
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K945031.
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
MULTIPLE
K945164 · Protection Gloves Sdn. Bhd. · Feb 1995
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)
K946155 · Mala Intertrade Co., Ltd. · Jan 1995
MALA LATEX EXAM GLOVES AND SCAN-SUB
K946154 · Lowenkamp Intl., Inc. · Jan 1995
PATIENT EXAMINATION GLOVE
K933602 · Kerala Rubber & Reclaims, Ltd. · Jan 1995
PATIENT EXAINATION GLOVES
K945045 · Phoenix Medical Technology, Inc. · Jan 1995
K945031 · ROYALSHIELD NON-STERILE POWDER-FREE
Download PDF FDA Summary Shield Gloves Manufac…