510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882583Substantially Equivalent

Latex Exam Gloves, Non-Sterile

B und J Instruments, City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882583 is the FDA 510(k) clearance record for LATEX EXAM GLOVES, NON-STERILE, a class I device, cleared for B Und J Instruments on under FDA product code FMC (Patient Examination Glove). FDA records list one 510(k) clearance for B Und J Instruments. As of , FDA records show no recalls naming K882583.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FMC Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
B Und J Instruments P.O. Box 3945, City Of Industry CA
Third party review
No

Clearances, product code FMC

Trailing 12 months

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

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