The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Latex Surgical Gloves, Powder Free With Protein Claim (50 Micrograms Or Less).
| Device ID | K211621 |
| 510k Number | K211621 |
| Device Name: | Latex Surgical Gloves, Powder Free With Protein Claim (50 Micrograms Or Less) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-26 |
| Decision Date | 2021-10-06 |