Cleared Traditional

K022336 - BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD

K022336 is an FDA 510(k) clearance for BALDUR BRAND VINYL POWDERED EXAMINATION..., 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 85-day FDA review.

K022336 · 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
Oct 2002
Decision
85d
Days
Class 1
Risk

K022336 is an FDA 510(k) clearance for the BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD. 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 October 11, 2002 after a review of 85 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 - K022336

510(k) Number K022336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date October 11, 2002
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K022336.
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
K023343 · Shanghai Palomar Mountain Industries, Inc. · Oct 2002
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K022604 · Sun Flower Gloves Co., Ltd. · Oct 2002
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
K023235 · Shandong Jiazhan Plastic Products Co., Ltd. · Oct 2002
VINYL EXAMINATION GLOVES, PRE-POWDERED
K023145 · Shandong Jiazhan Plastic Products Co., Ltd. · Oct 2002
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K022600 · Shijiazhuang Wally Plastics Co., Ltd. · Sep 2002
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
K022639 · Shijiazhuang Holy Plastics Co., Ltd. · Sep 2002
K022336 · BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
Download PDF FDA Summary Tangshan Zhonghong Pu…