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510(k) K910920

PROTEKT GLOVES by Intermedics Orthopedics — Product Code FYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
March 5, 1991
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

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Other clearances for product code FYE

  • K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN (April 11, 1994)
  • K912790 — SURGICAL GOWN (September 19, 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)