510(k) K994081

SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES by Safeskin Corp. — Product Code KGO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 18, 2000
Date Received: December 3, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Surgeon'S Gloves
Device Class: Class I
Regulation Number: 878.4460
Review Panel: HO
Submission Type

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Safeskin Corp.

K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG O (March 2, 2000)
K992830 — SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NIT (October 27, 1999)
K992210 — SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (September 10, 1999)
K992162 — SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPE (August 30, 1999)
K992062 — SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (August 25, 1999)
K991951 — SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, W (July 26, 1999)
K991317 — POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF T (May 21, 1999)
K970899 — SAFESKIN POWDERED EXAMINATION GLOVE (May 6, 1997)
K962139 — SAFESKIN (December 19, 1996)
K952993 — SAFESKIN SUPRA (August 28, 1995)

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