Home / 510(k) Clearances / K932731

510(k) K932731

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN by Johnson & Johnson Medical, Inc. — Product Code FYE

K932731 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on April 11, 1994. The device falls under product code FYE (Dress, Surgical), a Class I device regulated under 21 CFR 878.4040. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1994
Date Received
June 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dress, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type

Other clearances by Johnson & Johnson Medical, Inc.

  • K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX (October 21, 2004)
  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

Other clearances for product code FYE

  • K912790 — SURGICAL GOWN (September 19, 1991)
  • K910920 — PROTEKT GLOVES (May 15, 1991)
  • K910941 — LIFELINER SURGICAL GLOVE (May 9, 1991)
  • K895667 — STERILE SURGICAL GOWN (October 13, 1989)
  • K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS (September 19, 1989)
  • K894760 — CLOTHINGUARD (August 18, 1989)

FDA data resources