Cleared Traditional

K000166 - SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES

K000166 is an FDA 510(k) clearance for SYNTHETIC (WHITE) VINAL POWDERED PATIEN..., manufactured by Shijiazhuang Great Eagle Plastic 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 34-day FDA review.

K000166 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
34d
Days
Class 1
Risk

K000166 is an FDA 510(k) clearance for the SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Great Eagle Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on February 22, 2000 after a review of 34 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.

View all Shijiazhuang Great Eagle Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K000166

510(k) Number K000166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2000
Decision Date February 22, 2000
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 206
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K000166.
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd. · Apr 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · Shijiazhuang Great Vision Plastic Products Co., LT · Mar 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2000
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K992979 · Shanghai Poseidon Plastic Products Co., Ltd. · Feb 2000
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994206 · Shijiazhuang Hongray Plastic Products Co., Ltd. · Feb 2000
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994222 · Shijiazhuang Hongray Plastic Products Co., Ltd. · Feb 2000