The following data is part of a premarket notification filed by Nathan Trading Co., Ltd with the FDA for Lydus Nitrite Examination Gloves, Powder Free.
| Device ID | K203191 |
| 510k Number | K203191 |
| Device Name: | LYDUS Nitrite Examination Gloves, Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Nathan Trading Co., Ltd 58 Moo 12 Palan Sub-District Nathan District, TH 34170 |
| Contact | Chansamone Saiyasak |
| Correspondent | Abdel B. Halim Global Quality And Regulatory Services 10 Scenic Way Monroe, NJ 08831 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-27 |
| Decision Date | 2021-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| LY0812669804287 | K203191 | 000 |
| LY0812669804286 | K203191 | 000 |
| LY0812669804285 | K203191 | 000 |
| LY081266980424 | K203191 | 000 |
| LY081266980423 | K203191 | 000 |
| LY08126698042 | K203191 | 000 |
| NTC08187899531 | K203191 | 000 |
| 00711583360954 | K203191 | 000 |