510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884295Substantially Equivalent

Surgical Apparel, Isolation Gown,mask,cap,sleeve

Saybrex Intl., Inc., Beverly Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884295 is the FDA 510(k) clearance record for SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE, a class II device, cleared for Saybrex Intl., Inc. on under FDA product code LGM (Chamber, Patient Isolation). FDA records list 2 510(k) clearances for Saybrex Intl., Inc. As of , FDA records show no recalls naming K884295.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LGM Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Applicant
Saybrex Intl., Inc. 215 1/2 S. Arnaz Dr., Beverly Hills CA
Third party review
No

Clearances, product code LGM

Trailing 12 months

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

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