The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Sterling Nitrile Powder-free Exam Glove (sterile).
| Device ID | K081027 |
| 510k Number | K081027 |
| Device Name: | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Richard W Wolfe |
| Correspondent | Richard W Wolfe KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-10 |
| Decision Date | 2008-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20036000531323 | K081027 | 000 |
| 30680651449888 | K081027 | 000 |
| 30680651449895 | K081027 | 000 |
| 30680651449901 | K081027 | 000 |
| 30680651449918 | K081027 | 000 |
| 30680651531309 | K081027 | 000 |
| 30680651531316 | K081027 | 000 |
| 30680651531323 | K081027 | 000 |
| 20036000531309 | K081027 | 000 |
| 20036000531316 | K081027 | 000 |
| 30680651449871 | K081027 | 000 |