The following data is part of a premarket notification filed by Allied Rubber Industries Sdn. Bhd. with the FDA for Patient Examination Gloves.
| Device ID | K892487 |
| 510k Number | K892487 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ALLIED RUBBER INDUSTRIES SDN. BHD. 2009, KAWASAN MIEL LOT 2, JALAN BEREMBAN 15/12, 400000 Shah Alam.malaysia, MY |
| Contact | Ee Ping |
| Correspondent | Ee Ping ALLIED RUBBER INDUSTRIES SDN. BHD. 2009, KAWASAN MIEL LOT 2, JALAN BEREMBAN 15/12, 400000 Shah Alam.malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-07-14 |