The following data is part of a premarket notification filed by Oon Corp. Resources with the FDA for Latex Examination Gloves.
| Device ID | K970770 |
| 510k Number | K970770 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | OON CORP. RESOURCES NO. 59, SENAWANG INDUST ESTATE 70450 SEREMBAN, NEGERI Sembilan, Malaysia, MY |
| Contact | Clement K K.oon |
| Correspondent | Clement K K.oon OON CORP. RESOURCES NO. 59, SENAWANG INDUST ESTATE 70450 SEREMBAN, NEGERI Sembilan, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040131477 | K970770 | 000 |
| 20304040131460 | K970770 | 000 |
| 20304040131453 | K970770 | 000 |
| 20304040131446 | K970770 | 000 |
| 20304040131439 | K970770 | 000 |