The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Latex Examination Glove, Powder Free With Protein Content Labeling Claim (50 Ug/g Or Less Of Total Extractable Protein).
| Device ID | K203705 |
| 510k Number | K203705 |
| Device Name: | Latex Examination Glove, Powder Free With Protein Content Labeling Claim (50 Ug/g Or Less Of Total Extractable Protein) |
| Classification | Latex Patient Examination Glove |
| Applicant | Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, MY 70450 |
| Contact | Lim Kwee Shyan |
| Correspondent | Lim Kwee Shyan Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, MY 70450 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-08-20 |