Cleared Traditional

K003232 - RS NITRILSTAT MEDICAL EXAMINATION GLOVES

K003232 is an FDA 510(k) clearance for RS NITRILSTAT MEDICAL EXAMINATION GLOVES, 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 9-day FDA review.

K003232 · Riverstone Resources Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
9d
Days
Class 1
Risk

K003232 is an FDA 510(k) clearance for the RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Riverstone Resources Sdn Bhd (Kepong Baru, Kuala Lumpur, MY). The FDA issued a Cleared decision on October 26, 2000 after a review of 9 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 Riverstone Resources Sdn Bhd devices

FDA 510(k) Submission Details - K003232

510(k) Number K003232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date October 26, 2000
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
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 685
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K003232.
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
K002064 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K001613 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422 · Shen Wei (Usa), Inc. · May 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · Sgmp Co., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · Siam Sempermed Corp., Ltd. · Apr 2000