The following data is part of a premarket notification filed by Central Medicare Sdn. Bhd. with the FDA for Orange Non Sterile Powder Free Nitrile Examination Gloves.
| Device ID | K172642 |
| 510k Number | K172642 |
| Device Name: | Orange Non Sterile Powder Free Nitrile Examination Gloves |
| 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 | 2017-09-01 |
| Decision Date | 2017-11-28 |
| Summary: | summary |