FDA Device Registration & Listing · Pathio Chumphon, TH · Registration 3021206557
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2009-03-18 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2009-03-18 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-12-06 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-11-29 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-11-13 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2020-11-13 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-11-13 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2007-12-27 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-09-04 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2017-11-29 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-03-03 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2023-03-03 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2023-03-03 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-03-03 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-09 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2020-04-09 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2020-04-09 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3008604557 | STGT Surat Thani | Phlai Wat , Kanchanadit Surat Thani, TH |
| 3020160813 | STGT-TG 1 | Kantang Trang, TH |
| 3021206556 | STGT ANV | Sadao Songkhla, TH |
| 3006979699 | VANDA GLOVE | Pahtong, Hat Yai Songkhla, TH |
| 3019849096 | STGT PS1 | Sadao Songkhla, TH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K981039 | Sri Johani Sdn. Bhd. | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | 1998-04-21 |
| K101595 | Better Care Plastic Technology Cp., Ltd. | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | 2010-08-06 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3030671502 | GUANGDONG VYIMED CO., LTD. | Qingyuan Guangdong, CN |
| 9610406 | ANSELL (THAILAND) LTD. | THAILAND Krung Thep Maha Nakhon, TH |
| 3026062711 | RMKH GLOVE (CAMBODIA) CO., LTD. | Bavet City Svay Rieng, KH |
| 3043739177 | US Paper Mill LLC | Chillicothe, OH, US |
| 3013681444 | ANREL DISTRIBUTION LLC | Jackson, NJ, US |
3021206557 when referencing this establishment in official correspondence.