510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K912040Substantially Equivalent

Latex Examination Gloves

Pt. Indoraya Everlatex, Indonesia(Kode Pos 70723), ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912040 is the FDA 510(k) clearance record for LATEX EXAMINATION GLOVES, a class I device, cleared for Pt. Indoraya Everlatex on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list one 510(k) clearance for Pt. Indoraya Everlatex. As of , FDA records show no recalls naming K912040.

Clearance record

Decision date
Received
(215 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Pt. Indoraya Everlatex Jln.A.Yani Km.22 Landasan Ulin, Indonesia(Kode Pos 70723), ID
510(k) summary
Statement
Third party review
No

Clearances, product code LYY

Trailing 12 months

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

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