Cleared Traditional

K962461 - NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES

K962461 is an FDA 510(k) clearance for NITRILE POWDER-FREE PATIENT EXAMINATION..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K962461 · Shen Wei (Usa), Inc. · General Hospital
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Aug 1996
Decision
50d
Days
Class 1
Risk

K962461 is an FDA 510(k) clearance for the NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 50 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K962461

510(k) Number K962461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1996
Decision Date August 14, 1996
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K962461.
SAFESKIN
K962139 · Safeskin Corp. · Dec 1996
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
K962518 · P.T. Irama Dinamika Latex · Dec 1996
CHLOROPRENE EXAM GLOVES
K963771 · P.T. Irama Dinamika Latex · Dec 1996
TACTYLON POWDER FREE EXAMINATION GLOVE
K955464 · Tactyl Technologies, Inc. · Apr 1996
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954573 · Tillotson Healthcare Corp. · Dec 1995
PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954574 · Tillotson Healthcare Corp. · Dec 1995