Cleared Traditional

K022091 - BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES

K022091 is an FDA 510(k) clearance for BALDUR BRAND VINYL POWDER-FREE EXAMINAT..., manufactured by Tangshan Zhonghong Pulin Group Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K022091 · Tangshan Zhonghong Pulin Group Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
186d
Days
Class 1
Risk

K022091 is an FDA 510(k) clearance for the BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Zhonghong Pulin Group Co., Ltd. (Union City, US). The FDA issued a Cleared decision on December 30, 2002 after a review of 186 days - an extended review 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: 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 - K022091

510(k) Number K022091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2002
Decision Date December 30, 2002
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
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 K022091.
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
K024174 · General Gloves Corp. · Jan 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K023728 · Canopus Medical Supply Co., Ltd. · Jan 2003
SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES
K024154 · Shanghai Huamao Gloves Co., Ltd. · Jan 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024026 · Shanghai PM Plastics Enterise Co., Ltd. · Dec 2002
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
K023560 · Shanghai Palomar Mountain Industries, Inc. · Dec 2002
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
K023343 · Shanghai Palomar Mountain Industries, Inc. · Oct 2002
K022091 · BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
Download PDF FDA Summary Tangshan Zhonghong Pu…