The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn Bhd with the FDA for Non-sterile, Pf Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs-blue.
| Device ID | K182383 |
| 510k Number | K182383 |
| Device Name: | Non-Sterile, PF Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs-Blue |
| Classification | Patient Examination Glove, Specialty |
| Applicant | YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020 |
| Contact | Punitha Samy |
| Correspondent | Punitha Samy YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-31 |
| Decision Date | 2019-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864069045 | K182383 | 000 |
| 20686864042123 | K182383 | 000 |
| 20686864042260 | K182383 | 000 |
| 20686864042390 | K182383 | 000 |
| 20686864042536 | K182383 | 000 |
| 00686864059547 | K182383 | 000 |
| 00686864059493 | K182383 | 000 |
| 20686864029001 | K182383 | 000 |
| 20686864039017 | K182383 | 000 |
| 20686864049023 | K182383 | 000 |
| 20686864059039 | K182383 | 000 |
| 20686864041980 | K182383 | 000 |