Cleared Traditional

K061659 - POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K061659 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Tangshan Luxiong Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K061659 · Tangshan Luxiong Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
95d
Days
Class 1
Risk

K061659 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Luxiong Plastic Products Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on September 15, 2006 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061659

510(k) Number K061659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date September 15, 2006
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

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 Peers - LYZ Vinyl Patient Examination Glove

All 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K061659.
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K062882 · Suqian Green Glove Co., Ltd. · Oct 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES
K062520 · Jiangsu Jaysun Glove Co., Ltd. · Oct 2006
POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K062655 · Shijiazhuang Junfei Plastic Products Co., Ltd. · Sep 2006
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K061662 · Tangshan Luxiong Plastic Products Co., Ltd. · Sep 2006
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K062522 · Jiangsu Jaysun Glove Co., Ltd. · Sep 2006
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
K061659 · POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Tangshan Luxiong Plas…