The following data is part of a premarket notification filed by Central Medicare Sdn. Bhd. with the FDA for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K172525 |
| 510k Number | K172525 |
| Device Name: | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Central Medicare Sdn. Bhd. PT 2609 - 2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Contact | Arivalagan Subramaniam |
| Correspondent | Arivalagan Subramaniam Central Medicare Sdn. Bhd. PT 2609 - 2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479186231 | K172525 | 000 |
| 00612479186316 | K172525 | 000 |
| 00612479186293 | K172525 | 000 |
| 00612479186279 | K172525 | 000 |
| 00612479186255 | K172525 | 000 |