The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Blue (colored).
| Device ID | K172015 |
| 510k Number | K172015 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) |
| Classification | Polymer Patient Examination Glove |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811114031237 | K172015 | 000 |
| 09551006060013 | K172015 | 000 |
| 09551006060020 | K172015 | 000 |
| 09551006060037 | K172015 | 000 |
| 09551006060044 | K172015 | 000 |
| 09551006060051 | K172015 | 000 |
| 00811114031190 | K172015 | 000 |
| 00811114031206 | K172015 | 000 |
| 00811114031213 | K172015 | 000 |
| 00811114031220 | K172015 | 000 |
| 09551006060006 | K172015 | 000 |