BERGAMOT SDN BHD

FDA Device Registration & Listing · KAJANG Selangor, MY · Registration 3014743234

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
3014743234
FEI Number
3014743234
Entity Name
BERGAMOT SDN BHD
City/State/Country
KAJANG Selangor, MY
Establishment Address
NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN, KAJANG Selangor 43000, MY
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
BERGAMOT SDN BHD (Owner Number: 10079487)
Owner / Operator Contact Address
NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN, KAJANG, MY-10 43000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K993811
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2020-12-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-12-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-12-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-12-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-12-09
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-12-09

Official Correspondent

SITI KARTIKA HAMDAN

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

BERGAMOT 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

Similar Registrations

Registration Number Establishment Name Location
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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 3014743234. Last updated year: 2026. Please use registration number 3014743234 when referencing this establishment in official correspondence.
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