Data / Medical devices / Hong Kong / Pamitex Inc Limited
Pamitex Inc Limited: FDA-registered device maker in Kowloon, Hong Kong, 14 510(k) clearances
Pamitex Inc Limited is registered with the FDA (registration 3009229300) in Kowloon, Hong Kong. It lists 4 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009229300
- Address
- Unit 170, Houston Centre 63 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, 999077
- Owner or operator
- Pamitex Inc Limited (10060254)
- Roles
- Exporter to the US
- First device listed
- April 16, 2019
- Registered through
- 2026
- Brand names listed
- HEALTH-PLUS SANITEX RELIANCE, Microflex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2022 | K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | LZA | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| October 23, 2019 | K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| May 2, 2012 | K120184 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED | LZA | Substantially Equivalent | Encompass Medical Supplies Inc Limited | accessdata.fda.gov |
| June 30, 2000 | K001674 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| June 30, 2000 | K000952 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| June 23, 2000 | K001672 | POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| April 28, 2000 | K993756 | HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES | KGO | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| April 7, 2000 | K000828 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| March 29, 2000 | K993201 | HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| February 10, 2000 | K993918 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| October 18, 1999 | K992523 | HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| August 30, 1999 | K992223 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| August 25, 1999 | K992165 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
| August 23, 1999 | K992299 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
Updated May 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.