Cleared Traditional

K101565 - POWDER - FREE PATIENT EXAMINATION GLOVES

K101565 is an FDA 510(k) clearance for POWDER - FREE PATIENT EXAMINATION GLOVES, manufactured by Zibio Yingjie Medical 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 74-day FDA review.

K101565 · Zibio Yingjie Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
74d
Days
Class 1
Risk

K101565 is an FDA 510(k) clearance for the POWDER - FREE PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibio Yingjie Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on August 17, 2010 after a review of 74 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 - K101565

510(k) Number K101565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date August 17, 2010
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K101565.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100421 · Tangshan Yonkshun Glove, Co., Ltd. · Sep 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102098 · Hong DI Plastic Products Co., Ltd. · Sep 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101358 · Hebei Handform Plastic Products Co., Ltd. · Aug 2010
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
K100977 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
K100978 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100963 · Hebei Shenzichen Plastic & Rubber Products Co., LT · Aug 2010
K101565 · POWDER - FREE PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Zibio Yingjie Medical…