Cleared Traditional

K053259 - DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE

K053259 is an FDA 510(k) clearance for DISPOSABLE PVC EXAMINATION GLOVE, manufactured by Practical Protective Plastic Manufactory , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K053259 · Practical Protective Plastic Manufactory , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
57d
Days
Class 1
Risk

K053259 is an FDA 510(k) clearance for the DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Practical Protective Plastic Manufactory , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 18, 2006 after a review of 57 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 - K053259

510(k) Number K053259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2005
Decision Date January 18, 2006
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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

Tuv America, Inc.
LAURA DANIELSON

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 - LYZ Vinyl Patient Examination Glove

All 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K053259.
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Feb 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · Shijiazhuang Brilliant Ocean Plastic Co., Ltd. · Jan 2006
POWDER FREE VINYL EXAMINATION GLOVE
K052985 · Tg Medical (China) Incorporation · Jan 2006
POWDERED VINYL EXAMINATION GLOVE
K052984 · Tg Medical (China) Incorporation · Jan 2006
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
K052923 · Great Glove (China), Inc. · Dec 2005
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES
K052922 · Great Glove (China), Inc. · Dec 2005

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.

K053259 · DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
Download PDF FDA Summary Practical Protective …