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510(k) K913700

DISPOSABLE BOUFFANT CAP by Gem Nonwovews, Inc. — Product Code FYF

K913700 is an FDA 510(k) premarket notification submitted by Gem Nonwovews, Inc. for the device "DISPOSABLE BOUFFANT CAP". The FDA issued a decision of Substantially Equivalent on October 4, 1991. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Gem Nonwovews, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1991
Date Received
August 19, 1991
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 Gem Nonwovews, Inc.

  • K913628 — DISPOSABLE SHOE COVER (October 4, 1991)

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)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • 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