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 Latex Examination Glove.
| Device ID | K212309 |
| 510k Number | K212309 |
| Device Name: | Non-sterile, Powder-Free Latex Examination Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | Sri Trang Gloves (Thailand) Public Company Limited 10 SOi 10 Phetkasem Road Hatyai, TH 90110 |
| Contact | Jarinya Jirojkul |
| Correspondent | M. Jordan Smith Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, FL 33607 -1785 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850044458336 | K212309 | 000 |
| 10850044458322 | K212309 | 000 |
| 20850044458312 | K212309 | 000 |
| 20850044458305 | K212309 | 000 |
| 20850044458299 | K212309 | 000 |