Cleared Traditional

K022671 - FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES

K022671 is an FDA 510(k) clearance for FREEFORM BLUE POWDERFREE NITRILE EXAMIN..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K022671 · Hartalega Sdn Bhd · General Hospital
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Nov 2002
Decision
98d
Days
Class 1
Risk

K022671 is an FDA 510(k) clearance for the FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Reno, US). The FDA issued a Cleared decision on November 18, 2002 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K022671

510(k) Number K022671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2002
Decision Date November 18, 2002
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 907
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K022671.
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · Perusahaan Getah Asas Sdn. Bhd. · Jan 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025 · Kossan Latex Industries(M)Sdn Bhd · Dec 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · Syntex Healthcare Products Co., Ltd. · Nov 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · Allegiance Healthcare Corp. · Oct 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · Allegiance Healthcare Corp. · Oct 2002