The following data is part of a premarket notification filed by Quality Gallant Sdn. Bhd. with the FDA for Powdered Latex Examination Gloves.
| Device ID | K071323 |
| 510k Number | K071323 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak, MY 34700 |
| Contact | Seah B Hoon |
| Correspondent | Seah B Hoon QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak, MY 34700 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-06-22 |
| Summary: | summary |