Cleared Traditional

K003675 - SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES

K003675 is an FDA 510(k) clearance for SHANGHAI CHINA STAR CORP POWDERED BLUE ..., 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 41-day FDA review.

K003675 · Shanghai China Star Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
41d
Days
Class 1
Risk

K003675 is an FDA 510(k) clearance for the SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT 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 January 9, 2001 after a review of 41 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 - K003675

510(k) Number K003675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2000
Decision Date January 09, 2001
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 129d · This submission: 41d
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 Consultant

Entela, Inc.
NED DEVINE JR

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K003675.
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
K003985 · Guthrie Medicare Products (Melaka) Sdn Bhd · Feb 2001
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
K010247 · Shanghai China Star Corp · Feb 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
K003563 · Ning BO Yujiang Rubber & Plastic Co. · 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

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K003675 · SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shanghai China Star C…