510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K944778Substantially Equivalent

Latex Examination Gloves

Pt. Haloni Jane, Medan, ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944778 is the FDA 510(k) clearance record for LATEX EXAMINATION GLOVES, cleared for Pt. Haloni Jane on under FDA product code OPE. FDA records list 2 510(k) clearances for Pt. Haloni Jane, from to . As of , FDA records show no recalls naming K944778.

Clearance record

Decision date
Received
(51 days to decision)
Product code
OPE
Review panel
General Hospital
Applicant
Pt. Haloni Jane 8-I, Jalan Kapten Maulana, Medan, ID
510(k) summary
Statement
Third party review
No

Clearances, product code OPE

Trailing 12 months

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

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