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510(k) K910920

PROTEKT GLOVES by Intermedics Orthopedics — Product Code FYE

K910920 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "PROTEKT GLOVES". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code FYE (Dress, Surgical), a Class I device regulated under 21 CFR 878.4040. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

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

Other clearances by Intermedics Orthopedics

  • K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI (July 3, 1997)
  • K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS (April 30, 1997)
  • K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM (April 8, 1997)
  • K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (February 27, 1997)
  • K964357 — NATURAL-HIP SYSTEM COCR STEM (January 27, 1997)
  • K964350 — MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA (January 16, 1997)
  • K962190 — PATELLOFEMORAL JOINT PROSTHESIS (October 28, 1996)
  • K963266 — NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED (October 15, 1996)
  • K963155 — INTERMOORE FRACTURE HIP STEM (MODIFY) (October 1, 1996)
  • K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (September 3, 1996)

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)

FDA data resources