510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974442Substantially Equivalent

Pre-Powdered Nitrile Examination Gloves

P.T. Latexindo Tobaperkasa, Medan, ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974442 is the FDA 510(k) clearance record for PRE-POWDERED NITRILE EXAMINATION GLOVES, a class II device, cleared for P.T. Latexindo Tobaperkasa on under FDA product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball). FDA records list 3 510(k) clearances for P.T. Latexindo Tobaperkasa, from to . As of , FDA records show no recalls naming K974442.

Clearance record

Decision date
Received
(41 days to decision)
Product code
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
P.T. Latexindo Tobaperkasa Jalan Raya Binjai Km. 11., Medan, ID
510(k) summary
Statement
Third party review
No

Clearances, product code LZY

Trailing 12 months

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

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