The following data is part of a premarket notification filed by Koon Seng Sdn.bhd with the FDA for Royal Imperial Powdered Latex Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less).
| Device ID | K013537 |
| 510k Number | K013537 |
| Device Name: | ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | KOON SENG SDN.BHD PTD 3274 BATU 4 1/2 JALAN BAKRI Muar Johor, MY 84200 |
| Contact | Lim Weng Heng |
| Correspondent | Lim Weng Heng KOON SENG SDN.BHD PTD 3274 BATU 4 1/2 JALAN BAKRI Muar Johor, MY 84200 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2001-12-07 |