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510(k) K880481

CARETEX SURGEON'S CAPS by James River Corp. — Product Code FYF

K880481 is an FDA 510(k) premarket notification submitted by James River Corp. for the device "CARETEX SURGEON'S CAPS". The FDA issued a decision of Substantially Equivalent on February 24, 1988. The device falls under product code FYF (Cap, Surgical), 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
February 24, 1988
Date Received
February 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
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)
  • K892580 — CARETOUCH EXAMINATION GLOVES (July 14, 1989)
  • K893939 — ISOLATION MASKS (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)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)

Other clearances for product code FYF

  • K972227 — SHOE COVER (September 9, 1997)
  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954556 — SURGICAL CAP (March 12, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K913700 — DISPOSABLE BOUFFANT CAP (October 4, 1991)
  • K882346 — INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (June 30, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)

FDA data resources