The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Colored (green, Orange, Purple, White, & Black).
| Device ID | K220859 |
| 510k Number | K220859 |
| Device Name: | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, MY 70450 |
| Contact | Lim Kwee Shyan |
| 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 | 2022-03-24 |
| Decision Date | 2022-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551006061454 | K220859 | 000 |
| 09551006061447 | K220859 | 000 |
| 09551006061430 | K220859 | 000 |
| 09551006061423 | K220859 | 000 |
| 09551006061416 | K220859 | 000 |
| 09551006061409 | K220859 | 000 |