The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kimberly-clark Purple Nitrile Powder-free Exam Glove (chemotherapy Glove) And Kimberly-clark Purple Nitrile Xtra Powder-.
| Device ID | K101596 |
| 510k Number | K101596 |
| Device Name: | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- |
| Classification | Patient Examination Glove, Specialty |
| Applicant | KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30097 |
| Contact | Lester F Padilla |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036012550803 | K101596 | 000 |
| 10036000550815 | K101596 | 000 |
| 10036000550822 | K101596 | 000 |
| 10036000550839 | K101596 | 000 |
| 10036000550846 | K101596 | 000 |
| 10036008550831 | K101596 | 000 |
| 10036009550823 | K101596 | 000 |
| 10036010550812 | K101596 | 000 |
| 10036011550842 | K101596 | 000 |
| 10036000550808 | K101596 | 000 |