The following data is part of a premarket notification filed by Betel Care Sdn. Bhd. with the FDA for Betel Gloves Nitrile Examination Glove Powder Free.
| Device ID | K222342 |
| 510k Number | K222342 |
| Device Name: | Betel Gloves Nitrile Examination Glove Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Betel Care Sdn. Bhd. Lot 3342, Jalan Keretapi Lama 7 ½ Miles, Off Jalan Kapar, MY 42200 |
| Contact | Abdul Rahman Richard Abdullah |
| Correspondent | Manoj Zacharias Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-09-24 |