510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912042Substantially Equivalent

Bethel Plus Multiple Names

Bethel Latex Products, Inc., Haz;Ejirst MS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912042 is the FDA 510(k) clearance record for BETHEL PLUS MULTIPLE NAMES, a class I device, cleared for Bethel Latex Products, Inc. on under FDA product code LZB (Finger Cot). FDA records list one 510(k) clearance for Bethel Latex Products, Inc. As of , FDA records show no recalls naming K912042.

Clearance record

Decision date
Received
(55 days to decision)
Product code
LZB Finger Cot
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Bethel Latex Products, Inc. C/O Lowenkamp Intl., Inc., Haz;Ejirst MS
510(k) summary
Summary
Third party review
No

Clearances, product code LZB

Trailing 12 months

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

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