Cleared Traditional

K010663 - POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE

K010663 is an FDA 510(k) clearance for POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE, 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 24-day FDA review.

K010663 · Tong Ruhn Medical Products Co., Ltd. · General Hospital
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Mar 2001
Decision
24d
Days
Class 1
Risk

K010663 is an FDA 510(k) clearance for the POWDERED 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 March 30, 2001 after a review of 24 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 - K010663

510(k) Number K010663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date March 30, 2001
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K010663.
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K010671 · Tong Ruhn Medical Products Co., Ltd. · Apr 2001
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
K010830 · General Gloves Corp. · Apr 2001
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K010829 · General Gloves Corp. · Apr 2001
VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
K003197 · Kaohsiung Brothers Products Corp. · Nov 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
K003321 · Shanghai Antares Industries, Inc. · Nov 2000
MULTIPLE-VINYL EXAM GLOVE, POWDERED
K003133 · Excellence Ent. Co., Ltd. · Nov 2000
K010663 · POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
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