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510(k) K984392

ANSELL CONDOMS by Ansell, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1999
Date Received
December 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Ansell, Inc.

  • K983518 — LIFESTYLES XTRA PLEASURE (July 6, 1999)
  • K940047 — SPERMICIDALLY LUBRICATED CONDOM (December 19, 1995)
  • K953379 — HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE (September 27, 1995)
  • K945766 — HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (August 7, 1995)
  • K945767 — POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES (March 2, 1995)
  • K940045 — CONDOM (January 30, 1995)
  • K940046 — NON-LUBRICATED CONDOM (January 30, 1995)
  • K913766 — ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES (March 11, 1993)
  • K914760 — LATEX EXAMINATION GLOVES (January 17, 1992)
  • K903107 — PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) (August 29, 1990)

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