The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Innovative Gloves Latex Examination Gloves Powderfree With Protein Labeling Claim [50 Micrograms Or Less].
| Device ID | K993567 |
| 510k Number | K993567 |
| Device Name: | INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] |
| Classification | Latex Patient Examination Glove |
| Applicant | INNOVATIVE GLOVES CO; LTD 11 CHOTEVITTAYAKUL 3 RD. Hatyai, Songkhla, TH |
| Contact | Rajeev Kumar Sood |
| Correspondent | Rajeev Kumar Sood INNOVATIVE GLOVES CO; LTD 11 CHOTEVITTAYAKUL 3 RD. Hatyai, Songkhla, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 2000-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00759326684141 | K993567 | 000 |
| 00759326684134 | K993567 | 000 |
| 00759326684127 | K993567 | 000 |
| 00759326684110 | K993567 | 000 |
| 00759326684103 | K993567 | 000 |