Nitrilist Gloves Manufacturing Sdn Bhd

KUALA PILAH, Negeri Sembilan, MY

NITRILIST GLOVES MANUFACTURING SDN BHD appears in FDA device records in KUALA PILAH, Negeri Sembilan, MY. FDA records list 2 510(k) clearances between 2012-12-10 and 2013-01-18, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Nitrilist Gloves Manufacturing Sdn Bhd between 2012 and 2013. The busiest year on record is 2012, with 1. The most recent is 2013, with 1.

Clearances by year, as a table

510(k) clearance decisions for Nitrilist Gloves Manufacturing Sdn Bhd, by decision year
Year	Clearances
2012	1
2013	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K123328	POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK	LZA	Substantially Equivalent	2013-01-18
K122874	POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE	LZA	Substantially Equivalent	2012-12-10

Registered establishments

FDA registered establishments for Nitrilist Gloves Manufacturing Sdn Bhd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3010811068	3010811068	NITRILIST GLOVES MANUFACTURING SDN BHD	PT 197,KAWASAN PERINDUSTRIAN DIOH,, KUALA PILAH, Negeri Sembilan 72000 MY	2026	LZA

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

LZAPolymer Patient Examination Glove

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain