Cleared Traditional

K010247 - SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES

K010247 is an FDA 510(k) clearance for SHANGHAI CHINASTAR POWER-FREE BLUE NITR..., manufactured by Shanghai China Star Corp. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K010247 · Shanghai China Star Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
11d
Days
Class 1
Risk

K010247 is an FDA 510(k) clearance for the SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shanghai China Star Corp (Shanghai, CN). The FDA issued a Cleared decision on February 6, 2001 after a review of 11 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 Shanghai China Star Corp devices

FDA 510(k) Submission Details - K010247

510(k) Number K010247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2001
Decision Date February 06, 2001
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 861
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K010247.
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · La Glove (M) Sdn. Bhd. · Apr 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097 · Shen Wei (Usa), Inc. · Mar 2001
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
K010297 · Maxxim Medical · Feb 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391 · Siam Sempermed Corp., Ltd. · Dec 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · Siam Sempermed Corp., Ltd. · Nov 2000