510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921058Substantially Equivalent

Disposable Isolation Gown

Nat'L Surtex Corp., Paterson NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921058 is the FDA 510(k) clearance record for DISPOSABLE ISOLATION GOWN, a class II device, cleared for Nat'L Surtex Corp. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list one 510(k) clearance for Nat'L Surtex Corp. As of , FDA records show no recalls naming K921058.

Clearance record

Decision date
Received
(159 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nat'L Surtex Corp. 359 Mclean Blvd., Paterson NJ
510(k) summary
Statement
Third party review
No

Clearances, product code FYC

Trailing 12 months

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

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