510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895235Substantially Equivalent

Various Disposable Surgical Garments

Protect Corp. of Indiana, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895235 is the FDA 510(k) clearance record for VARIOUS DISPOSABLE SURGICAL GARMENTS, a class I device, cleared for Protect Corp. of Indiana, Inc. on under FDA product code FYE (Dress, Surgical). FDA records list one 510(k) clearance for Protect Corp. of Indiana, Inc. As of , FDA records show no recalls naming K895235.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FYE Dress, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Protect Corp. of Indiana, Inc. 3717 N. Rural, Indianapolis IN
Third party review
No

Clearances, product code FYE

Trailing 12 months

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

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