The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly Clark Purple Nitrile, And Purple Nitrile Xtra Powder Free Exam Glove.
| Device ID | K113423 |
| 510k Number | K113423 |
| Device Name: | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Lester F Padilla |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036017550907 | K113423 | 000 |
| 30680651504877 | K113423 | 000 |
| 30680651504860 | K113423 | 000 |
| 30680651453007 | K113423 | 000 |
| 30680651452994 | K113423 | 000 |
| 30680651452987 | K113423 | 000 |
| 30680651452970 | K113423 | 000 |
| 30680651452963 | K113423 | 000 |
| 30680651395086 | K113423 | 000 |
| 30680651395079 | K113423 | 000 |
| 30680651395062 | K113423 | 000 |
| 30680651395055 | K113423 | 000 |
| 30680651504884 | K113423 | 000 |
| 30680651504891 | K113423 | 000 |
| 30680651504907 | K113423 | 000 |
| 10036016506042 | K113423 | 000 |
| 10036015506012 | K113423 | 000 |
| 10036014506020 | K113423 | 000 |
| 10036013506038 | K113423 | 000 |
| 10036000550907 | K113423 | 000 |
| 10036000506041 | K113423 | 000 |
| 10036000506034 | K113423 | 000 |
| 10036000506027 | K113423 | 000 |
| 10036000506010 | K113423 | 000 |
| 90680651508532 | K113423 | 000 |
| 90680651508525 | K113423 | 000 |
| 30680651395048 | K113423 | 000 |