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510(k) K881396

OPERATING ROOM TOWELS -STERILE & NON-STERILE by A Plus International, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1988
Date Received
April 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
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)
  • 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)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 1988)

Other clearances for product code KKX

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  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)