510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K892111Substantially Equivalent

Patient Examination Gloves (Latex)

Maika Holdings Sdn. Bhd., Tun Ismail, 50350 Kuala, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892111 is the FDA 510(k) clearance record for PATIENT EXAMINATION GLOVES (LATEX), a class I device, cleared for Maika Holdings Sdn. Bhd. 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 Maika Holdings Sdn. Bhd. As of , FDA records show no recalls naming K892111.

Clearance record

Decision date
Received
(52 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Maika Holdings Sdn. Bhd. 3rd Floor , Menara Manickavasagam, Tun Ismail, 50350 Kuala, MY
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