510(k) K022784

SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR by Syntex Healthcare Products Co., Ltd. — Product Code LZA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 13, 2002
Date Received: August 22, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Polymer Patient Examination Glove
Device Class: Class I
Regulation Number: 880.6250
Review Panel: HO
Submission Type

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.

Other clearances by Syntex Healthcare Products Co., Ltd.

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K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (April 21, 2011)
K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (October 4, 2010)
K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (November 8, 2005)
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K033777 — ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (February 5, 2004)
K023826 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR (January 24, 2003)
K022146 — SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE (September 3, 2002)
K022090 — SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE (September 3, 2002)

Other clearances for product code LZA

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K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe (October 23, 2025)
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K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit (August 21, 2025)
K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, (August 18, 2025)
K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D (July 30, 2025)
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