510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K141467Substantially Equivalent

Surgical Gown

Xuchang Zhengde Environstar Medical Products Co.,L, Guangzhou, Guangdong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141467 is the FDA 510(k) clearance record for SURGICAL GOWN, a class II device, cleared for Xuchang Zhengde Environstar Medical Products Co.,L on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for Xuchang Zhengde Environstar Medical Products Co.,L. As of , FDA records show no recalls naming K141467.

Clearance record

Decision date
Received
(275 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Xuchang Zhengde Environstar Medical Products Co.,L 7th Foor Jingui Business Bldg. #982, Guangzhou, Guangdong, CN
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 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