Cleared Traditional

K992162 - SAFESKIN PURPLE POWDER-FREE NITRILE EXA...

K992162 is an FDA 510(k) clearance for SAFESKIN PURPLE POWDER-FREE NITRILE EXA..., manufactured by Safeskin Corp.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992162 · Safeskin Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
66d
Days
Class 1
Risk

K992162 is an FDA 510(k) clearance for the SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHER.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Safeskin Corp. (San Diego, US). The FDA issued a Cleared decision on August 30, 1999 after a review of 66 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 Safeskin Corp. devices

FDA 510(k) Submission Details - K992162

510(k) Number K992162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1999
Decision Date August 30, 1999
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

LZC Device Classification - Class 1, General Controls

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 50
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K992162.
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
K032444 · Cardinalhealth · Nov 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2003
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
NITRILE GLOVES
K970135 · Sage Products, Inc. · Aug 1997
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990