Cleared Traditional

K020868 - CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)

K020868 is an FDA 510(k) clearance for CASHMERE NON-STERILE, manufactured by Seal Polymer Industries Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K020868 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
35d
Days
Class 1
Risk

K020868 is an FDA 510(k) clearance for the CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Lahat, Ipoh, Perak, MY). The FDA issued a Cleared decision on April 22, 2002 after a review of 35 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 Seal Polymer Industries Bhd. devices

FDA 510(k) Submission Details - K020868

510(k) Number K020868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date April 22, 2002
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 863
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K020868.
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
K021013 · Smart Glove Corp. Sdn Bhd · May 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
K021396 · Wrp Specialty Products Sdn. Bhd. · May 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751 · Syntex Healthcare Products Co., Ltd. · May 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · Syntex Healthcare Products Co., Ltd. · Feb 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317 · Sgmp Co., Ltd. · Feb 2002
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001