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
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K971920Substantially Equivalent

Gown Poly Reinforced Large(product No.900-522)/(Reorder No. 0522)

Customed, Inc, Fajardo PR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971920 is the FDA 510(k) clearance record for GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522), a class II device, cleared for Customed, Inc. on under FDA product code FYA (Gown, Surgical). FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show 10 recalls naming K971920.

Clearance record

Decision date
Received
(195 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Customed, Inc. Calle Igualdad #7, Fajardo PR
510(k) summary
Statement
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260