3A Glove Sdn. Bhd.

Senai Johor, MY

3A GLOVE SDN. BHD. appears in FDA device records in Senai Johor, MY. FDA records list 2 510(k) clearances between 2023-09-29 and 2023-10-06, 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 3A Glove Sdn. Bhd. in 2023.

Clearances by year, as a table

510(k) clearance decisions for 3A Glove Sdn. Bhd., by decision year
Year	Clearances
2023	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K230777	Patient Examination Gloves	LZA	Substantially Equivalent	2023-10-06
K230847	Chemotherapy Gloves	LZA	Substantially Equivalent	2023-09-29

Registered establishments

FDA registered establishments for 3A Glove Sdn. Bhd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3025606191	3025606191	3A GLOVE SDN. BHD.	PTD 114733, Jalan Cyber 4, Kawasan Perindustrian Senai (III), Senai Johor 81400 MY	2026	LZA LZC OPJ

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

FDA product codes

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