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510(k) K830394

PROVIDONE-IODINE PREP-PADS & TOWELETTES by H & P Industries, Inc. — Product Code GEC

K830394 is an FDA 510(k) premarket notification submitted by H & P Industries, Inc. for the device "PROVIDONE-IODINE PREP-PADS & TOWELETTES". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. H & P Industries, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
February 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by H & P Industries, Inc.

  • K901217 — TRIA-SONIC ULTRA SOUND TRANSMISSION GEL (June 22, 1990)
  • K871169 — LUBRICATING JELLY (April 1, 1987)
  • K860961 — GAMMA RADIATION STERILIZED ALCOHOL PREP PADS (April 9, 1986)
  • K830393 — PROVIDONE-IODINE SWABSTICKS (April 6, 1983)

Other clearances for product code GEC

  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)

FDA data resources