510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211538Substantially Equivalent

Protect X Level 3 Isolation Gown

AZAC Group, City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211538 is the FDA 510(k) clearance record for Protect X Level 3 Isolation Gown, a class II device, cleared for Azac Group on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 2 510(k) clearances for Azac Group, from to . As of , FDA records show no recalls naming K211538.

Clearance record

Decision date
Received
(183 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Azac Group 17870 Castleton St., City Of Industry CA
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