510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892791Substantially Equivalent

Patient Examination Gloves (Latex)

Union Industrial Co., Ltd., Bangkrut Pha Smutpar, TH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892791 is the FDA 510(k) clearance record for PATIENT EXAMINATION GLOVES (LATEX), a class I device, cleared for Union Industrial Co., Ltd. on under FDA product code IMM (Footrest, Wheelchair). FDA records list 3 510(k) clearances for Union Industrial Co., Ltd., from to . As of , FDA records show no recalls naming K892791.

Clearance record

Decision date
Received
(135 days to decision)
Product code
IMM Footrest, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Union Industrial Co., Ltd. 45 Mu 2 Soi Thai Aree,, Bangkrut Pha Smutpar, TH
Third party review
No

Clearances, product code IMM

Trailing 12 months

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

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