The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Purple Nitrile Xtra* Sterile Powder-free Exam Glove (chemotherapy Glove) - 12 Sterile Pairs.
| Device ID | K102032 |
| 510k Number | K102032 |
| Device Name: | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS |
| 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 | 2010-07-19 |
| Decision Date | 2010-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20036000550911 | K102032 | 000 |
| 30680651504969 | K102032 | 000 |
| 30680651521010 | K102032 | 000 |
| 30680651521027 | K102032 | 000 |
| 30680651521034 | K102032 | 000 |
| 30680651550911 | K102032 | 000 |
| 30680651550928 | K102032 | 000 |
| 30680651550935 | K102032 | 000 |
| 30680651142598 | K102032 | 000 |
| 30680651142604 | K102032 | 000 |
| 30680651142611 | K102032 | 000 |
| 30680651142628 | K102032 | 000 |
| 30680651142635 | K102032 | 000 |
| 20036000521010 | K102032 | 000 |
| 20036000521027 | K102032 | 000 |
| 20036000521034 | K102032 | 000 |
| 20036000550928 | K102032 | 000 |
| 20036000550935 | K102032 | 000 |
| 30680651504952 | K102032 | 000 |