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 Violet Blue Tested For Use With Chemotherapy Drugs And Fentanyl And Non-sterile, Powder-free Nitrile Examination Glove Blue Tested For Use With Chemotherapy Drugs And Fentanyl.
| Device ID | K221165 |
| 510k Number | K221165 |
| Device Name: | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested For Use With Chemotherapy Drugs And Fentanyl And Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested For Use With Chemotherapy Drugs And Fentanyl |
| Classification | Polymer Patient Examination Glove |
| Applicant | Sri Trang Gloves (Thailand) Public Company Limited 110 Kanjanavanit Road Hat Yai, TH 80230 |
| Contact | Jordan Smith |
| Correspondent | Jordan Smith Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, FL 33607 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-22 |
| Decision Date | 2022-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864061445 | K221165 | 000 |
| 20686864061438 | K221165 | 000 |
| 20686864061421 | K221165 | 000 |
| 00686864061410 | K221165 | 000 |
| 20686864061407 | K221165 | 000 |
| 00686864061397 | K221165 | 000 |
| 20686864061384 | K221165 | 000 |
| 20686864061377 | K221165 | 000 |