Cleared Traditional

K030529 - LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE

K030529 is an FDA 510(k) clearance for LEGEND (BRAND) NITRILE POWDER-FREE PATI..., manufactured by Jda (Tianjin) Plastic Rubber Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K030529 · Jda (Tianjin) Plastic Rubber Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
170d
Days
Class 1
Risk

K030529 is an FDA 510(k) clearance for the LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jda (Tianjin) Plastic Rubber Co., Ltd. (Beijing 100022, CN). The FDA issued a Cleared decision on August 8, 2003 after a review of 170 days - an extended review 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: 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.

FDA 510(k) Submission Details - K030529

510(k) Number K030529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date August 08, 2003
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K030529.
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011 · Pt. Wrp Buana Multicorpora · Aug 2003
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
K032077 · Seal Polymer Industries Bhd. · Aug 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
K031157 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Aug 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
K031625 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
K031768 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
K031580 · Green Prospect Sdn Bhd · Jul 2003
K030529 · LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
Download PDF FDA Summary Jda (Tianjin) Plastic…