510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942200Substantially Equivalent

Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps

Thantex Specialties, Inc., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942200 is the FDA 510(k) clearance record for ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS, a class I device, cleared for Thantex Specialties, Inc. on under FDA product code LYU (Accessory, Surgical Apparel). FDA records list 21 510(k) clearances for Thantex Specialties, Inc., from to . As of , FDA records show no recalls naming K942200.

Clearance record

Decision date
Received
(459 days to decision)
Product code
LYU Accessory, Surgical Apparel
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Thantex Specialties, Inc. 4320 International Blvd., Norcross GA
510(k) summary
Statement
Third party review
No

Clearances, product code LYU

Trailing 12 months

FDA records hold no clearances under product code LYU in the trailing twelve months.

FDA records show no clearances under product code LYU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260