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510(k) K952241

PROTOUCH OVERGLOVE by Cottrell, Ltd. — Product Code MMP

K952241 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "PROTOUCH OVERGLOVE". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1995
Date Received
May 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Cottrell, Ltd.

  • K972708 — ENDO-SPOR PLUS / HYPROCIDE (September 13, 1999)
  • K970726 — VAPOCIDE (May 18, 1998)
  • K960089 — PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR (April 4, 1996)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K932922 — PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR (July 3, 1995)
  • K951983 — IMNI-II (June 20, 1995)
  • K945575 — PRO BARRIER(TM) TUBE SOX(TM) (March 6, 1995)
  • K893802 — PROVIEW SELF-SEALING STERILIZATION POUCH (April 4, 1990)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)

FDA data resources