The following data is part of a premarket notification filed by Semperit Investments Asia Pte. Ltd. with the FDA for Non-sterile, Single Use, Powder-free Examination Glove Tested For Use With Chemotherapy Drugs.
| Device ID | K171378 |
| 510k Number | K171378 |
| Device Name: | Non-Sterile, Single Use, Powder-free Examination Glove Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore, SG |
| Contact | Clemens Eichler |
| Correspondent | Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court Roswell, GA 30075 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2017-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841277100679 | K171378 | 000 |
| 00841277106435 | K171378 | 000 |
| 00841277106442 | K171378 | 000 |
| 00841277106459 | K171378 | 000 |
| 00841277106466 | K171378 | 000 |
| 00841277106473 | K171378 | 000 |
| 00841277105865 | K171378 | 000 |
| 00841277105872 | K171378 | 000 |
| 00841277105889 | K171378 | 000 |
| 00841277105896 | K171378 | 000 |
| 00841277105926 | K171378 | 000 |
| 00841277100570 | K171378 | 000 |
| 00841277100594 | K171378 | 000 |
| 00841277100600 | K171378 | 000 |
| 00841277100617 | K171378 | 000 |
| 00841277100624 | K171378 | 000 |
| 00841277106428 | K171378 | 000 |