The following data is part of a premarket notification filed by Careglove Global Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves, Blue Chemotest.
| Device ID | K211666 |
| 510k Number | K211666 |
| Device Name: | Powder Free Nitrile Examination Gloves, Blue Chemotest |
| Classification | Polymer Patient Examination Glove |
| Applicant | Careglove Global SDN. BHD. Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senawang Industrial Estate Seremban, MY 70450 |
| Contact | Siti Khatijah Ahmad |
| Correspondent | Siti Khatijah Ahmad Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, MY 70450 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2022-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551006060839 | K211666 | 000 |
| 09551006060617 | K211666 | 000 |
| 09551006060600 | K211666 | 000 |
| 09551006060594 | K211666 | 000 |
| 09551006060587 | K211666 | 000 |
| 09551006060570 | K211666 | 000 |