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510(k) K882283

BOUFFANT CAP by A Plus International, Inc. — Product Code FYF

K882283 is an FDA 510(k) premarket notification submitted by A Plus International, Inc. for the device "BOUFFANT CAP". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. A Plus International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
May 31, 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 A Plus International, Inc.

  • K213001 — Procedure Mask, Surgical Mask (May 11, 2022)
  • K102861 — SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINA (January 13, 2011)
  • K093169 — SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL G (November 12, 2009)
  • K031353 — SOLUTION FACE MASKS (June 19, 2003)
  • K882280 — COVER, SHOE OPERATING ROOM (June 23, 1988)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K882281 — GOWN, ISOLATION, SURGICAL (FYC) (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE (April 29, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 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