The following data is part of a premarket notification filed by He Chuang Plastic & Rubber Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs.
| Device ID | K182554 |
| 510k Number | K182554 |
| Device Name: | Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | He Chuang Plastic & Rubber Co., Ltd 6-27, Qilu International Plastic Park, Linzi Zibo, CN 255400 |
| Contact | Coco Wang |
| Correspondent | Coco Wang He Chuang Plastic & Rubber Co., Ltd 6-27, Qilu International Plastic Park, Linzi Zibo, CN 255400 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847713000558 | K182554 | 000 |
| 00847713000435 | K182554 | 000 |
| 00847713000411 | K182554 | 000 |
| 00847713000398 | K182554 | 000 |
| 00847713000510 | K182554 | 000 |