The following data is part of a premarket notification filed by Ideal Quality Sdn., Bhd. with the FDA for Multiple Name.
| Device ID | K103337 |
| 510k Number | K103337 |
| Device Name: | MULTIPLE NAME |
| Classification | Polymer Patient Examination Glove |
| Applicant | IDEAL QUALITY SDN., BHD. LOT 2796, 17 1/2 MILES JALAN KAPAR Klang, MY 42200 |
| Contact | Sh Tan |
| Correspondent | Sh Tan IDEAL QUALITY SDN., BHD. LOT 2796, 17 1/2 MILES JALAN KAPAR Klang, MY 42200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2011-02-25 |
| Summary: | summary |