Cleared Traditional

K021220 - NITRILE PATIENT EXAMINATION GLOVE POWDE...

K021220 is the FDA 510(k) clearance for NITRILE PATIENT EXAMINATION GLOVE POWDE... by Siam Sempermed Corp., Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K021220 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
76d
Days
Class 1
Risk

K021220 is an FDA 510(k) clearance for the NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WIT.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Palm Harbor, US). The FDA issued a Cleared decision on June 6, 2002 after a review of 76 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 Siam Sempermed Corp., Ltd. devices

Submission Details

510(k) Number K021220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date June 06, 2002
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 498
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K021220.
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · Kimberly-Clark Corp. · Jun 2005
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000
DISPOSABLE POLY GLOVES
K841676 · Abco Dealers, Inc. · May 1984