The following data is part of a premarket notification filed by Oon Corp. Resources with the FDA for Latex Examination Gloves, Powdered, (contains 100 Micrograms Or Less Of Total Water Extractable Protein Per Gram)..
| Device ID | K002448 |
| 510k Number | K002448 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). |
| Classification | Latex Patient Examination Glove |
| Applicant | OON CORP. RESOURCES 59 SENAWANG INDUSTRIAL ESTATE Seremban, MY 70450 |
| Contact | Clement K K Oon |
| Correspondent | Clement K K Oon OON CORP. RESOURCES 59 SENAWANG INDUSTRIAL ESTATE Seremban, MY 70450 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2000-09-11 |