The following data is part of a premarket notification filed by Oon Corp. Resources with the FDA for Powder Free (chlorinated) Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K981917 |
| 510k Number | K981917 |
| Device Name: | POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| 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 | 1998-06-01 |
| Decision Date | 1998-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040110076 | K981917 | 000 |
| 20304040101364 | K981917 | 000 |
| 20304040101371 | K981917 | 000 |
| 20814739020178 | K981917 | 000 |
| 20814739020185 | K981917 | 000 |
| 20814739020192 | K981917 | 000 |
| 20304040110038 | K981917 | 000 |
| 20304040110045 | K981917 | 000 |
| 20304040110052 | K981917 | 000 |
| 20304040110069 | K981917 | 000 |
| H65810351232 | K981917 | 000 |