510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971917Substantially Equivalent

Kentron's Isolation Gown

Kentron Health Care, Inc., Springfield TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971917 is the FDA 510(k) clearance record for KENTRON'S ISOLATION GOWN, a class II device, cleared for Kentron Health Care, Inc. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 6 510(k) clearances for Kentron Health Care, Inc., from to . As of , FDA records show no recalls naming K971917.

Clearance record

Decision date
Received
(119 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kentron Health Care, Inc. 3604 Kelton Jackson Rd., Springfield TN
510(k) summary
Summary
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