Cleared Traditional

K000226 - DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

K000226 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, manufactured by Sheen More Ent. Co., Ltd.. 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.

K000226 · Sheen More Ent. Co., Ltd. · General Hospital
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Mar 2000
Decision
35d
Days
Class 1
Risk

K000226 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sheen More Ent. Co., Ltd. (Tou-Liu, Yun-Lin, TW). The FDA issued a Cleared decision on March 2, 2000 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 Sheen More Ent. Co., Ltd. devices

FDA 510(k) Submission Details - K000226

510(k) Number K000226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date March 02, 2000
Days to Decision 35 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
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 977
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K000226.
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
K993805 · Best Manufacturing Company · Mar 2000
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876 · Shen Wei (Usa), Inc. · Feb 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246 · Omnigrace , Ltd. · Jan 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · Glove Source, Inc. · Jan 2000