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 Low Dermatitis And Fentanyl Permeation Resistance Claim.
| Device ID | K183149 |
| 510k Number | K183149 |
| Device Name: | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Low Dermatitis And Fentanyl Permeation Resistance Claim |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Central Medicare Sdn. Bhd. PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Contact | Muhammad Abdul Rahman |
| Correspondent | Muhammad Abdul Rahman Central Medicare Sdn. Bhd. PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Product Code | LZC |
| Subsequent Product Code | LZA |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-07-04 |