Cleared Traditional

K013998 - POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES

K013998 is an FDA 510(k) clearance for POWDER-FREE LAVENDER/PURPLE NITRILE EXA..., 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 71-day FDA review.

K013998 · Sheen More Ent. Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
71d
Days
Class 1
Risk

K013998 is an FDA 510(k) clearance for the POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sheen More Ent. Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on February 13, 2002 after a review of 71 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 - K013998

510(k) Number K013998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date February 13, 2002
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K013998.
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
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · Tillotson Healthcare Corp. · Oct 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001