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510(k) K093169

SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) by A Plus International, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2009
Date Received
October 7, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
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)
  • K031353 — SOLUTION FACE MASKS (June 19, 2003)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K882280 — COVER, SHOE OPERATING ROOM (June 23, 1988)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882281 — GOWN, ISOLATION, SURGICAL (FYC) (June 23, 1988)
  • K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE (April 29, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 1988)

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