Cleared Traditional

K943043 - ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM

K943043 is an FDA 510(k) clearance for ROYAL SHIELD NON-STERILE LATEX EXAM GLO..., 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 91-day FDA review.

K943043 · Shield Gloves Manufacturer (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
91d
Days
Class 1
Risk

K943043 is an FDA 510(k) clearance for the ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM. 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 September 26, 1994 after a review of 91 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 - K943043

510(k) Number K943043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date September 26, 1994
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K943043.
LATEX EXAMINATION GLOVES
K943707 · Arista Latindo Industrial Ltd. P.T · Nov 1994
COMFIT (STERILE)
K944141 · Wembley Rubber Products (M) Sdn Bhd · Oct 1994
ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE
K943807 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY
K943044 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994
MICRO-TOUCH LATEX MEDICAL GLOVES
K943620 · Johnson & Johnson Medical, Inc. · Sep 1994
SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)
K942510 · Wembley Rubber Products (M) Sdn Bhd · Aug 1994