Cleared Traditional

K010671 - POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE

K010671 is an FDA 510(k) clearance for POWDER FREE SYNTHETIC VINYL PATIENT EXA..., manufactured by Tong Ruhn 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 34-day FDA review.

K010671 · Tong Ruhn Medical Products Co., Ltd. · General Hospital
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Apr 2001
Decision
34d
Days
Class 1
Risk

K010671 is an FDA 510(k) clearance for the POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tong Ruhn Medical Products Co., Ltd. (Mc Henry, US). The FDA issued a Cleared decision on April 9, 2001 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 Tong Ruhn Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K010671

510(k) Number K010671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date April 09, 2001
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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 353
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K010671.
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
K023754 · Arista Latindo Industrial Ltd. P.T · Mar 2003
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · Allegiance Healthcare Corp. · May 2001
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · Arista Latindo Industrial Ltd. P.T · Oct 2000