The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Encore Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs.
| Device ID | K202765 |
| 510k Number | K202765 |
| Device Name: | ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs |
| 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 | 2020-09-21 |
| Decision Date | 2021-05-27 |