Cleared Traditional

K090691 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K090691 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shijiazhuang Benestar 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 52-day FDA review.

K090691 · Shijiazhuang Benestar Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
52d
Days
Class 1
Risk

K090691 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Benestar Plastic Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 7, 2009 after a review of 52 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 - K090691

510(k) Number K090691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date May 07, 2009
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 750
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K090691.
VINYL POWDERED EXAMINATION GLOVE
K091427 · Shun DA (Xinghua) Co., Ltd. · Jun 2009
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
K090520 · Shandong Huayue Glove Co., Ltd. · May 2009
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · Shandong Huayue Glove Co., Ltd. · May 2009
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · Quantum Co., Ltd. · Apr 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · Tangshan Jiteng Plastic Products Co., Ltd. · Mar 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · Zibo Goldenline Plastic Product Co., Ltd. · Mar 2009
K090691 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Shijiazhuang Benestar…