The following data is part of a premarket notification filed by Hl Rubber Industries Sdn Bhd with the FDA for Powder Nitrile Examination Glove (white And Blue Color).
| Device ID | K063522 |
| 510k Number | K063522 |
| Device Name: | POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, Negeri Sembilan, MY 72000 |
| Contact | Kenny Hoe |
| Correspondent | Kenny Hoe HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, Negeri Sembilan, MY 72000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2007-02-08 |