The following data is part of a premarket notification filed by Koon Seng Sdn.bhd with the FDA for Royal Imperial Powder Free Polymer Coated Latex Examination Glove With Protein Content Labeling Claim (50 Micrograms Or.
| Device ID | K012714 |
| 510k Number | K012714 |
| Device Name: | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR |
| Classification | Latex Patient Examination Glove |
| Applicant | KOON SENG SDN.BHD BATU 4 1/2 JALAN BAKRI Muar, Johor, MY 84000 |
| Contact | Lim Weng Heng |
| Correspondent | Lim Weng Heng KOON SENG SDN.BHD BATU 4 1/2 JALAN BAKRI Muar, Johor, MY 84000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2001-10-31 |