The following data is part of a premarket notification filed by Sri Trang Gloves (thailand) Public Company Limited with the FDA for Non-sterile, Powder-free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl.
| Device ID | K200539 |
| 510k Number | K200539 |
| Device Name: | Non-sterile, Powder-Free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl |
| Classification | Polymer Patient Examination Glove |
| Applicant | Sri Trang Gloves (Thailand) Public Company Limited 10 SOi 10 Phetkasem Road Hatyai, TH 90110 |
| Contact | Jarinya Jirojkul |
| Correspondent | Jordan Smith Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, FL 33607 -1785 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850044458011 | K200539 | 000 |
| 10850044458087 | K200539 | 000 |
| 10850044458070 | K200539 | 000 |
| 10850044458063 | K200539 | 000 |
| 10850044458056 | K200539 | 000 |