The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Latex Examination Glove Powder Free.
| Device ID | K152593 |
| 510k Number | K152593 |
| Device Name: | LATEX EXAMINATION GLOVE POWDER FREE |
| 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 | 2015-09-10 |
| Decision Date | 2016-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007817 | K152593 | 000 |
| 30851253007800 | K152593 | 000 |
| 30851253007794 | K152593 | 000 |
| 30851253007787 | K152593 | 000 |