510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894064Substantially Equivalent

Sterile Hand Cover

Sage Products LLC, Cary IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894064 is the FDA 510(k) clearance record for STERILE HAND COVER, a class I device, cleared for Sage Products, Inc. on under FDA product code LYU (Accessory, Surgical Apparel). FDA records list 31 510(k) clearances for Sage Products, Inc., from to . As of , FDA records show no recalls naming K894064.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LYU Accessory, Surgical Apparel
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sage Products, Inc. 680 Industrial Dr., Cary IL
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