Cleared Traditional

K091429 - VINYL POWDER FREE EXAMINATION GLOVE

K091429 is an FDA 510(k) clearance for VINYL POWDER FREE EXAMINATION GLOVE, manufactured by Shun DA (Xinghua) Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K091429 · Shun DA (Xinghua) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
70d
Days
Class 1
Risk

K091429 is an FDA 510(k) clearance for the VINYL POWDER FREE EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shun DA (Xinghua) Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on July 22, 2009 after a review of 70 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 - K091429

510(k) Number K091429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date July 22, 2009
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
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 K091429.
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
K091421 · Novapro Co., Ltd. · Jul 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES
K082647 · Tangshan Dar Plastic & Rubber Products Co. , Ltd. · Jul 2009
VINYL POWDER FREE EXAMINATION GLOVE
K091383 · Shun Tong Co., Ltd. · Jul 2009
VINYL POWDERED EXAMINATION GLOVE
K091384 · Shun Tong Co., Ltd. · Jul 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K091523 · Shijiazhuang Century Plastic Co., Ltd. · Jul 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K091431 · Zibo Yusheng Plastic Products Co., Ltd. · Jul 2009
K091429 · VINYL POWDER FREE EXAMINATION GLOVE
Download PDF Shun DA (Xinghua) Co.…