The following data is part of a premarket notification filed by Hl Rubber Industries Sdn Bhd with the FDA for Powder-free Nitrile Gloves, Black.
| Device ID | K100369 |
| 510k Number | K100369 |
| Device Name: | POWDER-FREE NITRILE GLOVES, BLACK |
| Classification | Polymer Patient Examination Glove |
| Applicant | HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, Negeri Sembilan, MY 72000 |
| Contact | Lau Siong Hut |
| Correspondent | Lau Siong Hut 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 | 2010-02-12 |
| Decision Date | 2010-05-20 |