Cleared Traditional

K092617 - ROYAL GUARD

K092617 is an FDA 510(k) clearance for ROYAL GUARD, manufactured by Shun Thai Rubber Gloves Industry Public Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K092617 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
267d
Days
Class 1
Risk

K092617 is an FDA 510(k) clearance for the ROYAL GUARD. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shun Thai Rubber Gloves Industry Public Co., Ltd. (Alexandria, US). The FDA issued a Cleared decision on May 20, 2010 after a review of 267 days - an extended review 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: 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 Shun Thai Rubber Gloves Industry Public Co., Ltd. devices

FDA 510(k) Submission Details - K092617

510(k) Number K092617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2009
Decision Date May 20, 2010
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 794
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092617.
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · Sgmp Co., Ltd. · Sep 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K091851 · Gx Corporation Sdn Bhd · Dec 2009