510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223467Substantially Equivalent

Disposable Isolation Gown

Nanning Tecbod Biological Technology Co.,Ltd, Naning, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223467 is the FDA 510(k) clearance record for Disposable Isolation Gown, a class II device, cleared for Nanning Tecbod Biological Technology Co., Ltd. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 2 510(k) clearances for Nanning Tecbod Biological Technology Co., Ltd., from to . As of , FDA records show no recalls naming K223467.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nanning Tecbod Biological Technology Co., Ltd. Rm. 601 Fool 6, B2 Bldg., # 19 Guokai Dadao,, Naning, CN
510(k) summary
Summary PDF
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