510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K101468Substantially Equivalent

3M Basic Disposable Surgical Gown, 3M Hp Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable

3M Company, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101468 is the FDA 510(k) clearance record for 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE, a class II device, cleared for 3M Company Corp on under FDA product code FYA (Gown, Surgical). FDA records list 146 510(k) clearances for 3M Company Corp, from to . As of , FDA records show no recalls naming K101468.

Clearance record

Decision date
Received
(322 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
3M Company Corp 3m Center, Bldg. 275-5w-06, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYA

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