Cleared Special

K010297 - SENSICARE SYNTHETIC POWDER FREE SURGICA...

K010297 is an FDA 510(k) clearance for SENSICARE SYNTHETIC POWDER FREE SURGICA..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code LZA cleared through the Special 510(k) pathway after a 16-day FDA review.

K010297 · Maxxim Medical · General Hospital
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Feb 2001
Decision
16d
Days
Class 1
Risk

K010297 is an FDA 510(k) clearance for the SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Maxxim Medical (Hone Path, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K010297

510(k) Number K010297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date February 16, 2001
Days to Decision 16 days
Submission Type Special
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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K010297.
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719 · Perusahaan Getah Asas Sdn. Bhd. · Apr 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · Shen Wei (Usa), Inc. · Apr 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097 · Shen Wei (Usa), Inc. · Mar 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391 · Siam Sempermed Corp., Ltd. · Dec 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · Siam Sempermed Corp., Ltd. · Nov 2000