Cleared Traditional

K021000 - SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES

K021000 is an FDA 510(k) clearance for SHANGHAI GLOVMAX ENTERPRISE POWDERED BL..., manufactured by Shanghai Glovmax Enterprise Co.,Ltd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K021000 · Shanghai Glovmax Enterprise Co.,Ltd · General Hospital
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May 2002
Decision
64d
Days
Class 1
Risk

K021000 is an FDA 510(k) clearance for the SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shanghai Glovmax Enterprise Co.,Ltd (Great Neck, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 64 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 Glovmax Enterprise Co.,Ltd devices

FDA 510(k) Submission Details - K021000

510(k) Number K021000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date May 31, 2002
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 861
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K021000.
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · Syntex Healthcare Products Co., Ltd. · Sep 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
K021452 · Maxxim Medical · Aug 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K021220 · Siam Sempermed Corp., Ltd. · Jun 2002
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
K021013 · Smart Glove Corp. Sdn Bhd · May 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
K021396 · Wrp Specialty Products Sdn. Bhd. · May 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751 · Syntex Healthcare Products Co., Ltd. · May 2002