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510(k) K883657

SKID RESISTANT, LONG LASTING SHOE COVERS by James River Corp. — Product Code FXP

K883657 is an FDA 510(k) premarket notification submitted by James River Corp. for the device "SKID RESISTANT, LONG LASTING SHOE COVERS". The FDA issued a decision of Substantially Equivalent on September 15, 1988. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. James River Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1988
Date Received
August 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Shoe, Operating-Room
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by James River Corp.

  • K894505 — COTOLIN DRAIN SPONGE AND DRESSING SPONGE (September 15, 1989)
  • K894147 — VISULIN TRANSPARENT ADHESIVE DRESSING (August 9, 1989)
  • K894034 — MODIFIED LABELING OF SURGICAL GLOVES (July 14, 1989)
  • K893939 — ISOLATION MASKS (July 14, 1989)
  • K892580 — CARETOUCH EXAMINATION GLOVES (July 14, 1989)
  • K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES (April 20, 1989)
  • K883802 — CARETEX CENTRAL SUPPLY WRAP (October 21, 1988)
  • K884112 — CARETEX OR TOWEL (October 13, 1988)
  • K880481 — CARETEX SURGEON'S CAPS (February 24, 1988)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)

Other clearances for product code FXP

  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
  • K971191 — FAR-EAST SHOE COVERS (July 10, 1997)
  • K970815 — CONVERTORS IMPERVIOUS SHOE COVERS (March 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K932738 — KAPPLER PRO/VENT BOOT (March 29, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)

FDA data resources