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510(k) K992162

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM by Safeskin Corp. — Product Code LZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
June 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

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.

Other clearances by Safeskin Corp.

  • K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG O (March 2, 2000)
  • K994081 — SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (January 18, 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)
  • 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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