The following data is part of a premarket notification filed by Semperit Investments Asia Pte Ltd. with the FDA for Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs.
| Device ID | K183441 |
| 510k Number | K183441 |
| Device Name: | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, And 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 609434 |
| Contact | Andreas Woess |
| 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 | 2018-12-12 |
| Decision Date | 2019-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841277105490 | K183441 | 000 |
| 00841277105476 | K183441 | 000 |
| 00841277105421 | K183441 | 000 |
| 00841277105414 | K183441 | 000 |
| 00841277105407 | K183441 | 000 |
| 00841277105391 | K183441 | 000 |