510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891212Substantially Equivalent

Aprons, Scrubs Slacks & Tops, Patient Drape

Pro-Safe Professional Linens, Inc., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891212 is the FDA 510(k) clearance record for APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE, a class I device, cleared for Pro-Safe Professional Linens, Inc. on under FDA product code FXO (Suit, Surgical). FDA records list 7 510(k) clearances for Pro-Safe Professional Linens, Inc., from to . As of , FDA records show no recalls naming K891212.

Clearance record

Decision date
Received
(38 days to decision)
Product code
FXO Suit, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pro-Safe Professional Linens, Inc. 304 W. Main St., Grand Junction CO
Third party review
No

Clearances, product code FXO

Trailing 12 months

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

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