Cleared Traditional

K942940 - ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES

K942940 is an FDA 510(k) clearance for ROYAL SHIELD POWDER-FREE LATEX EXAMANAT..., 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 40-day FDA review.

K942940 · Shield Gloves Manufacturer (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
40d
Days
Class 1
Risk

K942940 is an FDA 510(k) clearance for the ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES. 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 August 1, 1994 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shield Gloves Manufacturer (M) Sdn Bhd devices

FDA 510(k) Submission Details - K942940

510(k) Number K942940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date August 01, 1994
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 403
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K942940.
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
HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
K942758 · Aladan Corp. · Jul 1994
COMFIT GREEN POWDERED EXAMINATION GLOVES
K936265 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
COMFIT PINK POWDERED EXAMINATION GLOVES
K936267 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994