510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210131Substantially Equivalent

ComfortGuard Surgical Isolation Gown

GRI-Alleset, Inc., Flowery Branch GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K210131 is the FDA 510(k) clearance record for ComfortGuard Surgical Isolation Gown, a class II device, cleared for Gri-Alleset, Inc. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 4 510(k) clearances for Gri-Alleset, Inc., from to . As of , FDA records show no recalls naming K210131.

Clearance record

Decision date
Received
(219 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gri-Alleset, Inc. 4142 Industry Way, Flowery Branch GA
510(k) summary
Statement
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