The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn. Bhd. with the FDA for Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl.
| Device ID | K192954 |
| 510k Number | K192954 |
| Device Name: | Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl |
| Classification | Polymer Patient Examination Glove |
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Contact | Ng Kok Howe |
| Correspondent | Ng Kok Howe Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-21 |
| Decision Date | 2020-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818634025357 | K192954 | 000 |
| 10818634025347 | K192954 | 000 |
| 00818634025333 | K192954 | 000 |
| 10818634025323 | K192954 | 000 |