510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821666Substantially Equivalent

Sterile Surgical Drapes

Phoenix Glove Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821666 is the FDA 510(k) clearance record for STERILE SURGICAL DRAPES, a class II device, cleared for Phoenix Glove Co. on under FDA product code FJZ (Declotting Tray, Kit (Including Contents)). FDA records list 6 510(k) clearances for Phoenix Glove Co., from to . As of , FDA records show no recalls naming K821666.

Clearance record

Decision date
Received
(14 days to decision)
Product code
FJZ Declotting Tray, Kit (Including Contents)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Phoenix Glove Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FJZ

Trailing 12 months

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

FDA records show no clearances under product code FJZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJZ, 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