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510(k) K942200

ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS by Thantex Specialties, Inc. — Product Code LYU

K942200 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1995
Date Received
May 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (July 18, 1997)
  • K961083 — OREX SURGEON'S VEST (August 23, 1996)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (June 16, 1995)
  • K945755 — OREX(R) O.R EQUIPMENT DRAPES (May 25, 1995)
  • K945223 — OREX ISOLATION GOWN (April 25, 1995)
  • K944859 — OREX SURGICAL DRAPES (February 28, 1995)
  • K944827 — OREX SURGEON'S GOWN (February 28, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K942228 — OREX O.R. TOWEL (December 20, 1994)
  • K940764 — OREX (December 19, 1994)

Other clearances for product code LYU

  • K011755 — STRYKER T4 HYTREL (R) TOGAS (June 22, 2001)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • K970988 — FAR-EAST BOUFFANT CAPS (July 10, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)

FDA data resources