The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark* Sterling* Nitrile Powder-free Examination Glove.
| Device ID | K051347 |
| 510k Number | K051347 |
| Device Name: | KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Richard V Wolfe |
| Correspondent | Richard V Wolfe KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-24 |
| Decision Date | 2005-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643022043 | K051347 | 000 |
| 00817643022036 | K051347 | 000 |