The following data is part of a premarket notification filed by Pt. Sintong Unigolden Glove with the FDA for Nitrile Examination Gloves Powder Free (tested For Use With Chemotherapy Drugs).
| Device ID | K223235 |
| 510k Number | K223235 |
| Device Name: | Nitrile Examination Gloves Powder Free (Tested For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. Sintong Unigolden Glove Jl. Lintas Sumatera, Kel. Hessa Perlompongan, Kec. Air Batu, Kab. Asahan Kota Kisaran, ID 21272 |
| Contact | MP Vivekanandan |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-13 |
| Decision Date | 2022-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08994452290138 | K223235 | 000 |
| 18994452290067 | K223235 | 000 |
| 18994452290050 | K223235 | 000 |
| 18994452290043 | K223235 | 000 |
| 18994452290036 | K223235 | 000 |
| 18994452290029 | K223235 | 000 |