The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Powder Free Chloroprene Examination Glove Coloured (blue, Green).
| Device ID | K213993 |
| 510k Number | K213993 |
| Device Name: | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) |
| 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 | Lim Kwee Shyan 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 | 2021-12-21 |
| Decision Date | 2022-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551006061331 | K213993 | 000 |
| 09551006061324 | K213993 | 000 |
| 09551006061317 | K213993 | 000 |
| 09551006061300 | K213993 | 000 |
| 09551006061294 | K213993 | 000 |