PENTAVEST HOLDINGS SDN BHD

FDA Device Registration & Listing · Batu Melaka, MY · Registration 3021915797

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021915797
FEI Number
3021915797
Entity Name
PENTAVEST HOLDINGS SDN BHD
City/State/Country
Batu Melaka, MY
Establishment Address
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga,, Batu Melaka 76400, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Pentavest Holdings Sdn Bhd (Owner Number: 10084568)
Owner / Operator Contact Address
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga,, Batu, MY-04 76400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212847
PMA Number
N/A

All Registered Proprietary Names

George glove Penta Glove

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Pentavest Holdings Sdn Bhd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21

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8041005 WRP ASIA PACIFIC SDN. BHD. SALAK TINGGI, SEPANG Selangor, MY
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021915797. Last updated year: 2026. Please use registration number 3021915797 when referencing this establishment in official correspondence.
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