PACEWELL ASIA SDN. BHD.

FDA Device Registration & Listing · Batu Gajah Perak, MY · Registration 3007791481

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
3007791481
FEI Number
3007791481
Entity Name
PACEWELL ASIA SDN. BHD.
City/State/Country
Batu Gajah Perak, MY
Establishment Address
No. 46-54 (PT9289, 9291, 9293-9297), Laluan Bemban, Kawasan Perindustrian Bemban, Batu Gajah Perak 31000, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Pacewell Asia Sdn. Bhd. (Owner Number: 10026951)
Owner / Operator Contact Address
55A, Medan Ipoh 1A, Medan Ipoh Bistari, Ipoh, MY-08 31400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Comfort Powder Free Latex Examination Gloves with Protein Content Labelling Claim Powder Free Nitrile (Orange) Examination Gloves Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim (Green)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-06-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-06-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-06-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-06-05

Official Correspondent

CHAN YEW MEN

US Agent Details

TERRELL CUNNINGHAM Business: T. Cunningham Consulting & Associates, LLC Email: cunninghamterrella@gmail.com Phone: (301) 5359600

Related Public Records

Same Entity

Pacewell Asia 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
K894452 Kerala Rubber & Reclaims, Ltd. KRR GLOVE, PATIENT EXAMINATION GLOVES 1989-08-09
K891323 Li Wah-Hong Kong, Inc. LI WAH LATEX EXAMINATION GLOVES 1989-08-31
K891418 C & K Mfg. & Sales Co. LATEX EXAMINATION GLOVES, STYLE 510 LX 1989-06-22
K994255 Pt. Maja Agung Latexindo LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE 2000-02-07
K892946 Yeou-Fwu Rubber Industrial Co., Ltd. STERILE PATIENT EXAMINATION GLOVES 1989-08-10

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1000266564 SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. Hat Yai Songkhla, TH
8040653 ARISTA LATINDO INDUSTRIAL, LTD. P.T. JAKARTA BARAT, ID
3002661124 ULINE, INC. Pleasant Prairie, WI, US
3019769825 HARTALEGA NGC SDN. BHD. (LOT 39496) Sepang Selangor, MY
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007791481. Last updated year: 2026. Please use registration number 3007791481 when referencing this establishment in official correspondence.
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