Cleared Traditional

K000058 - BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

K000058 is an FDA 510(k) clearance for BROTHERS POWDER-FREE VINYL EXAMINATION ..., manufactured by Kaohsiung Brothers Products Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K000058 · Kaohsiung Brothers Products Corp. · General Hospital
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Mar 2000
Decision
60d
Days
Class 1
Risk

K000058 is an FDA 510(k) clearance for the BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Kaohsiung Brothers Products Corp. (Kaohsiung, TW). The FDA issued a Cleared decision on March 10, 2000 after a review of 60 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 Kaohsiung Brothers Products Corp. devices

FDA 510(k) Submission Details - K000058

510(k) Number K000058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2000
Decision Date March 10, 2000
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 334
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K000058.
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · Evergreen Medical Produts (Jingxing) Co., Ltd. · May 2000
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