The following data is part of a premarket notification filed by Aspen Glove Sdn. Bhd. with the FDA for Blue Nitrile Examination Glove Powder Free.
| Device ID | K211479 |
| 510k Number | K211479 |
| Device Name: | Blue Nitrile Examination Glove Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Aspen Glove Sdn. Bhd. Aspen House, 300, JLN Macalister, Georgetown, MY 10450 |
| Contact | Iskandar Basha Bin Abdul Kadir |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-12 |
| Decision Date | 2021-09-16 |