Cleared Traditional

K962139 - SAFESKIN

K962139 is an FDA 510(k) clearance for SAFESKIN, manufactured by Safeskin Corp.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K962139 · Safeskin Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
199d
Days
Class 1
Risk

K962139 is an FDA 510(k) clearance for the SAFESKIN. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Safeskin Corp. (San Diego, US). The FDA issued a Cleared decision on December 19, 1996 after a review of 199 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safeskin Corp. devices

FDA 510(k) Submission Details - K962139

510(k) Number K962139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date December 19, 1996
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K962139.
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · Hartalega Sdn Bhd · Feb 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628 · Shen Wei (Usa), Inc. · Feb 1997
PATIENT EXAMINATION GLOVES
K964148 · Hartalega Sdn Bhd · Feb 1997
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
K962461 · Shen Wei (Usa), Inc. · Aug 1996
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051 · Wembley Rubber Products (M) Sdn Bhd · Dec 1995