510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895642Substantially Equivalent

Latex Patient Examination Gloves

Siam Sempermed Corp., Ltd., Thailand, TH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895642 is the FDA 510(k) clearance record for LATEX PATIENT EXAMINATION GLOVES, cleared for Siam Sempermed Corp., Ltd. on under FDA product code OPE. FDA records list 37 510(k) clearances for Siam Sempermed Corp., Ltd., from to . As of , FDA records show no recalls naming K895642.

Clearance record

Decision date
Received
(77 days to decision)
Product code
OPE
Review panel
General Hospital
Applicant
Siam Sempermed Corp., Ltd. 8-10 Jootee Anusorn Rd., Thailand, TH
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