The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Sterile Latex Surgical Glove, Powder Free.
| Device ID | K190241 |
| 510k Number | K190241 |
| Device Name: | Sterile Latex Surgical Glove, Powder Free |
| Classification | Surgeon's Gloves |
| Applicant | Careglove Global Sdn Bhd Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, MY 70450 |
| Contact | Lim Kwee Shyan |
| Correspondent | Lim Kwee Shyan Careglove Global Sdn Bhd Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In 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 | 2019-02-06 |
| Decision Date | 2019-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551006061058 | K190241 | 000 |
| 09551006061041 | K190241 | 000 |
| 09551006061034 | K190241 | 000 |
| 09551006060518 | K190241 | 000 |
| 09551006060501 | K190241 | 000 |
| 09551006060495 | K190241 | 000 |
| 09551006060488 | K190241 | 000 |
| 09551006060471 | K190241 | 000 |