Cleared Traditional

K013261 - MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE

K013261 is an FDA 510(k) clearance for MOTEX NITRILE EXAMINATION GLOVES POWDER..., manufactured by Shanghai Motex Healthcare Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K013261 · Shanghai Motex Healthcare Co., Ltd. · General Hospital
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Nov 2001
Decision
59d
Days
Class 1
Risk

K013261 is an FDA 510(k) clearance for the MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shanghai Motex Healthcare Co., Ltd. (Qingpu, Shanghai, CN). The FDA issued a Cleared decision on November 29, 2001 after a review of 59 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 Motex Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K013261

510(k) Number K013261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date November 29, 2001
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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

Center For Measurement Standards of Industrial
TZU-WEI LI

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 1165
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K013261.
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K013254 · Top Quality Mfg., Inc. · Feb 2002
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K014077 · Shijiazhuang Great Vision Plastic Products Co., LT · Feb 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
K013303 · Latexx Manufacturing Sdn.Bhd. · Jan 2002
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · Tillotson Healthcare Corp. · Oct 2001
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
K012786 · Shamrock Manufacturing Company · Oct 2001

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.