Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009229300

FEI Number

3009229300

Entity Name

PAMITEX INC LIMITED

City/State/Country

Kowloon, HK

Establishment Address

Unit 170, Houston Centre, 63 Mody Road, Tsim Sha Tsui, Kowloon 999077, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Pamitex Inc Limited (Owner Number: 10060254)

Owner / Operator Contact Address

Unit 170, Houston Centre, 63 Mody Road, Tsim Sha Tsui, Kowloon, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993918

PMA Number

N/A

All Registered Proprietary Names

HEALTH-PLUS SANITEX RELIANCE HEALTH-PLUS SANITEX RELIANCE HEALTH-PLUS SANITEX RELIANCE HEALTH-PLUS SANITEX RELIANCE Microflex HEALTH-PLUS SANITEX RELIANCE HEALTH-PLUS SANITEX RELIANCE HEALTH-PLUS SANITEX RELIANCE

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	2019-05-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-05-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-05-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-05-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-09-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-09-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-05-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-05-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-07-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-05-06

Official Correspondent

Stafanie Tan

US Agent Details

Jordan Chang Email: Jordan@encompass-medical.com Phone: (909) 8601908

Related Public Records

Same Entity

Pamitex Inc Limited

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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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 3009229300. Last updated year: 2026. Please use registration number 3009229300 when referencing this establishment in official correspondence.