Cleared Traditional

K014077 - POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES

K014077 is an FDA 510(k) clearance for POWDER FREE (BLUE) NITRILE PATIENT EXAM..., manufactured by Shijiazhuang Great Vision Plastic Products Co., LT. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K014077 · Shijiazhuang Great Vision Plastic Products Co., LT · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
55d
Days
Class 1
Risk

K014077 is an FDA 510(k) clearance for the POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shijiazhuang Great Vision Plastic Products Co., LT (Chino, US). The FDA issued a Cleared decision on February 4, 2002 after a review of 55 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 - K014077

510(k) Number K014077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date February 04, 2002
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K014077.
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317 · Sgmp Co., Ltd. · Feb 2002
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
K013998 · Sheen More Ent. Co., Ltd. · Feb 2002
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K013254 · Top Quality Mfg., Inc. · Feb 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
K013303 · Latexx Manufacturing Sdn.Bhd. · Jan 2002
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261 · Shanghai Motex Healthcare Co., Ltd. · Nov 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001
K014077 · POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Great Vi…