510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K180217Substantially Equivalent

VESTEX Apparel

Vestagen Protective Technologies, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180217 is the FDA 510(k) clearance record for VESTEX Apparel, a class II device, cleared for Vestagen Protective Technologies, Inc. on under FDA product code QBW (Surgical Apparel With Material Claims). FDA's definition for product code QBW reads: "Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms...". FDA records list one 510(k) clearance for Vestagen Protective Technologies, Inc. As of , FDA records show no recalls naming K180217.

Clearance record

Decision date
Received
(113 days to decision)
Product code
QBW Surgical Apparel With Material Claims
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Vestagen Protective Technologies, Inc. 1301 W. Colonial Dr., Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBW

Trailing 12 months

FDA records hold no clearances under product code QBW in the trailing twelve months.

FDA records show no clearances under product code QBW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBW, 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