Cleared Traditional

K100603 - RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

K100603 is an FDA 510(k) clearance for RS SAFE BLUE NITRILE MEDICAL EXAMINATIO..., manufactured by Riverstone Resources Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K100603 · Riverstone Resources Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
135d
Days
Class 1
Risk

K100603 is an FDA 510(k) clearance for the RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Riverstone Resources Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on July 16, 2010 after a review of 135 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 Riverstone Resources Sdn Bhd devices

FDA 510(k) Submission Details - K100603

510(k) Number K100603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2010
Decision Date July 16, 2010
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 1157
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K100603.
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
K101630 · Pt. Smartglove Indonesia · Sep 2010
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K100975 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K101595 · Better Care Plastic Technology Cp., Ltd. · Aug 2010
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
K100979 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Jul 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K101293 · Pt. Smartglove Indonesia · Jul 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
K093516 · Summit Glove, Inc. · Jun 2010