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510(k) K883802

CARETEX CENTRAL SUPPLY WRAP by James River Corp. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1988
Date Received
September 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
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)
  • K893939 — ISOLATION MASKS (July 14, 1989)
  • K894034 — MODIFIED LABELING OF SURGICAL GLOVES (July 14, 1989)
  • K892580 — CARETOUCH EXAMINATION GLOVES (July 14, 1989)
  • K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES (April 20, 1989)
  • K884112 — CARETEX OR TOWEL (October 13, 1988)
  • K883657 — SKID RESISTANT, LONG LASTING SHOE COVERS (September 15, 1988)
  • K880481 — CARETEX SURGEON'S CAPS (February 24, 1988)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)