Cleared Traditional

K952589 - ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES

K952589 is an FDA 510(k) clearance for ROYAL SHIELD PINK & BLUE COLORED NON-ST..., 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 67-day FDA review.

K952589 · 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
Aug 1995
Decision
67d
Days
Class 1
Risk

K952589 is an FDA 510(k) clearance for the ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shield Gloves Manufacturer (M) Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on August 11, 1995 after a review of 67 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.

FDA 510(k) Submission Details - K952589

510(k) Number K952589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date August 11, 1995
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 K952589.
ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE
K945504 · Ganz Industries Sdn. Bhd. · Aug 1995
GLOVETEX (MULTIPLE)
K952197 · Pt Mbf Buana Multicorpora · Aug 1995
ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
K952590 · Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · Aug 1995
ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES
K952591 · Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · Aug 1995
BOSTON MEDICAL LATEX EXAM GLOVES
K952695 · Shun Thai Rubber Gloves Industry Co., Ltd. · Aug 1995
SAFESKIN
K952793 · Safeskin Corp. · Aug 1995
K952589 · ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES
Download PDF FDA Summary Shield Gloves Manufac…