510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970814Substantially Equivalent

Non-Sterile Isolation Gown

American Seal Co., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970814 is the FDA 510(k) clearance record for NON-STERILE ISOLATION GOWN, a class II device, cleared for American Seal Co. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 6 510(k) clearances for American Seal Co., from to . As of , FDA records show no recalls naming K970814.

Clearance record

Decision date
Received
(82 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Seal Co. 25029 Viking St., Hayward CA
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