Cleared Traditional

K041848 - POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR

K041848 is an FDA 510(k) clearance for POLYMER COAT POWDER FREE NITRILE EXAMIN..., manufactured by Pt. Smartglove Indonesia. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K041848 · Pt. Smartglove Indonesia · General Hospital
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Aug 2004
Decision
43d
Days
Class 1
Risk

K041848 is an FDA 510(k) clearance for the POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Smartglove Indonesia (Tg Morawa-Deli Serdang, ID). The FDA issued a Cleared decision on August 20, 2004 after a review of 43 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.

FDA 510(k) Submission Details - K041848

510(k) Number K041848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2004
Decision Date August 20, 2004
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K041848.
CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
K042238 · Seal Polymer Industries Bhd. · Sep 2004
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
K042101 · Seal Polymer Industries Bhd. · Aug 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276 · Shanghai Motex Healthcare Co., Ltd. · Aug 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · Hartalega Sdn Bhd · Jul 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K040791 · Pt. Smartglove Indonesia · Jun 2004