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510(k) K972227

SHOE COVER by American Seal Co. — Product Code FYF

K972227 is an FDA 510(k) premarket notification submitted by American Seal Co. for the device "SHOE COVER". The FDA issued a decision of Substantially Equivalent on September 9, 1997. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. American Seal Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
June 13, 1997
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 American Seal Co.

  • K972187 — BOUFFANT CAP (September 9, 1997)
  • K970814 — NON-STERILE ISOLATION GOWN (May 27, 1997)
  • K964358 — AMSEAL SURGICAL FACE MASK (February 14, 1997)
  • K892557 — MAYTEX NON-STERILE LATEX EXAM GLOVE (May 31, 1989)
  • K892553 — MAYTEX PATIENT EXAMINATION GLOVES (May 25, 1989)

Other clearances for product code FYF

  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954556 — SURGICAL CAP (March 12, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K953878 — BOUFFANT 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)
  • K882283 — BOUFFANT CAP (June 23, 1988)

FDA data resources