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510(k) K864479

CARETEX ISOLUTION GOWNS by James River Corp. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1986
Date Received
November 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
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)
  • 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)
  • K883802 — CARETEX CENTRAL SUPPLY WRAP (October 21, 1988)
  • 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)

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  • K223467 — Disposable Isolation Gown (February 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (November 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G (October 21, 2022)
  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
  • K220528 — Surgical Isolation Cover Gown (June 10, 2022)