Cleared Traditional

K101343 - POWDERED VINYL PATIENT EXAMINATION GLOVES

K101343 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Shijiazhuang Star Plastic Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K101343 · Shijiazhuang Star Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
65d
Days
Class 1
Risk

K101343 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Star Plastic Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 16, 2010 after a review of 65 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 - K101343

510(k) Number K101343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date July 16, 2010
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
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 K101343.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101663 · Hebei Excellent Plastic Co., Ltd. · Jul 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101664 · Hebei Excellent Plastic Co., Ltd. · Jul 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100964 · Hebei Shenzichen Plastic & Rubber Products Co., LT · Jul 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101840 · Shijiazhuang Sail Plastic Co., Ltd. · Jul 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101841 · Shijiazhuang Sail Plastic Co., Ltd. · Jul 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100057 · Tangshan Kangyuan Glove Co., Ltd. · Jul 2010
K101343 · POWDERED VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Star Pla…