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) Official FDA 510(k) Summary (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.

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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092617.
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
K093517 · Summit Glove, Inc. · Jun 2010
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092874 · Quality Gallant Sdn. Bhd. · Jun 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010
POWDER-FREE NITRILE GLOVES, BLACK
K100369 · Hl Rubber Industries Sdn Bhd · May 2010
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
K092472 · Ascend Eagle, Inc. · Apr 2010
MULTIPLE PRIVATE LABEL
K100162 · Biogreen Yields Sdn.Bhd · Mar 2010
K092617 · ROYAL GUARD
Download PDF FDA Summary Shun Thai Rubber Glov…